{"id":1031,"date":"2017-10-20T12:18:47","date_gmt":"2017-10-20T11:18:47","guid":{"rendered":"https:\/\/www.groupactionlawyers.co.uk\/blog\/?p=1031"},"modified":"2017-10-20T12:18:47","modified_gmt":"2017-10-20T11:18:47","slug":"medical-device-alert-issued-vitek-2-test-ast-cards","status":"publish","type":"post","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/medical-device-alert-issued-vitek-2-test-ast-cards","title":{"rendered":"Medical device alert issued over damaged VITEK 2 test cards exposing risk to antibiotic degradation"},"content":{"rendered":"<p>The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert over <em>VITEK &reg; 2 AST Test Cards<\/em> after the discovery that when the cards are exposed to moisture, it can stop antibiotics from working.<\/p>\n<p>Manufacturer <em>BioM\u00e9rieux<\/em> published a Field Safety Notice to inform consumers of the issue at hand, and confirm the potential problems. The Notice explains that a defective test card may:<\/p>\n<div class=\"well\">\n<ul>\n<li>Yield false resistance for antibiotics on the AST panel<\/li>\n<li>Cause a false negative ESBL test<\/li>\n<li>Result in a false positive urea reaction on ID cards<\/li>\n<\/ul>\n<\/div>\n<p><!--more--><\/p>\n<h2>About the cards<\/h2>\n<p>The test cards are used for antimicrobial susceptibility testing to check bacteria and yeasts for susceptibility and resistance to antibiotics. Produced in a small pouch, the test cards are a fast and disposable detection method to help researchers and doctors find the right diagnosis, and therefore administer correct and effective treatment.<\/p>\n<h3>About the issue<\/h3>\n<p>The French biotechnology company who specialise in providing medical devices to identify disease and contamination looked into the issue and found that the incorrect stitch seal design combined with product shipping and handling may be the cause of the problem. Pictures of the defective pouch in which the test cards are held in show a small puncture or tear that looks like a small clamp has been pressed into it.<\/p>\n<p>BioM\u00e9rieux have since replaced the stitch seal wheels used in the manufacturing process, but continue to send out Field Safety Notices to consumers and call for directors of pathology, laboratory managers, and biomedical scientists in microbiology to follow the proposed action listed in the Medical Device Alert:<\/p>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered table-striped\">\n<tbody>\n<tr>\n<td>All relevant staff to acknowledge receipt of the field safety notice after reading through it.<\/td>\n<\/tr>\n<tr>\n<td>Do not use any pouches that are obviously defective through visual inspection. These are to be disposed of and relevant staff are requested to contact the manufacturer for replacements.<\/td>\n<\/tr>\n<tr>\n<td>Anyone who uses a non-visually defective test card is encouraged to be vigilant in obtaining test results and repeat testing if results are inconsistent with expectations and other results.<\/td>\n<\/tr>\n<tr>\n<td>If results continue to cause concern, use alternative methods or devices to test susceptibility and resistance.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p>Worryingly, it&#8217;s believed the test cards have been distributed to U.S Military and government sites as well as over 100 locations across the globe.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert over VITEK &reg; 2 AST Test Cards after the discovery that when the cards are exposed to moisture, it can stop antibiotics from working. Manufacturer BioM\u00e9rieux published a Field Safety Notice to inform consumers of the issue at hand, and confirm &hellip; <a href=\"https:\/\/www.groupactionlawyers.co.uk\/blog\/medical-device-alert-issued-vitek-2-test-ast-cards\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Medical device alert issued over damaged VITEK 2 test cards exposing risk to antibiotic degradation<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":328,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[5],"tags":[20],"class_list":["post-1031","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-mhra"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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The antibiotic is used to treat all sorts of bacterial\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"drugs alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/antibiotics-alert-min.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/antibiotics-alert-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/antibiotics-alert-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/antibiotics-alert-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":70,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/medical-device-alert-blood-glucose-monitors","url_meta":{"origin":1031,"position":1},"title":"Medical Device Alert &#8211; Blood glucose monitors","author":"Admin","date":"19th August 2016","format":false,"excerpt":"Blood glucose monitors that are for home use are at risk of producing false low blood glucose level results. 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The manufacturer produced a medical device field safety notice earlier in June warning users of the less than\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":1075,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/another-medical-device-alert-intra-aortic-balloon-pump-fault","url_meta":{"origin":1031,"position":4},"title":"Another Medical Device Alert for Intra-Aortic Balloon Pump for a different fault!","author":"Admin","date":"10th November 2017","format":false,"excerpt":"The Medicines and Healthcare products Regulatory Agency (MHRA) has issued another medical device alert for intra-aortic balloon pumps, made by Maquet\/Getinge. The alert closely follows the one issued over the Datascope Corp's similar devices that were found to have an electrical fault. This new alert identifies a \"false blood detection\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"medical device alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert-min.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":627,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/carefusion-syringe-pumps-incompatible-with-any-syringe-type","url_meta":{"origin":1031,"position":5},"title":"CareFusion syringe pumps are incompatible with any syringe type","author":"Admin","date":"27th April 2017","format":false,"excerpt":"Following on from medical device alerts from the Medicines and Healthcare products Regulatory Agency (MHRA), CareFusion has made updates and replacements to the MDA\/2016\/023 Alaris syringe pumps that were at risk of having uncontrolled bolus i.e. chewed up amounts of substances from the medicine. Medical device alert 1 On 22nd\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1031","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/comments?post=1031"}],"version-history":[{"count":2,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1031\/revisions"}],"predecessor-version":[{"id":1033,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1031\/revisions\/1033"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media\/328"}],"wp:attachment":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media?parent=1031"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/categories?post=1031"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/tags?post=1031"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}