Events

Safety Alert Or Field Safety Notices for VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by BioMérieux.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2017-08-14
  • Event Date Posted
    2017-08-14
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/vitek-2-identification-id-antimicrobial-susceptibility-test-ast-cards-potential-false-resistance-for-antibiotics-on-the-ast-panel-leading-to-false-negative-esbl-test-or-false-positive-urea-ure-reaction-on-id-cards
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
    If moisture gets into the damaged test card pouches, it can stop the antibiotics working properly.The manufacturer’s investigation found that the root cause of the problem was a combination of stitch
    seal wheel design/positioning on the manufacturing equipment, and product shipping/handling. The stitch seal wheels on the manufacturing equipment have now been replaced with a new design.
  • Reason
    Manufactured by biomérieux – due to a manufacturing issue, some test card pouches might be damaged, resulting in antibiotic degradation.
  • Action
    Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice and that they understand the problem and the actions to be taken. Destroy any defective cards Contact Biomerieux to acknowledge receipt of the Field Safety Notice (dated 20 April 2017) even if you don’t have affected devices left in stock. Consider the need to repeat test if you observe any of the following results from the affected lots: a resistant imipenem result, particularly if unexpected and/or inconsistent with other results a resistant or intermediate nitrofurantoin result which is unusual or inconsistent with other results a resistant oxacillin or erythromycin result which is unusual or inconsistent with other results any quality control test result with these agents that is outside of the expected range If concerns exist after repeat testing, alternative methods of establishing drug susceptibility should be used As part of your review processes, report any incorrect results to MHRA

Device

VITEK®2 Identification (ID) / Antimicrobial Susceptibility Test (AST) Cards
  • Model / Serial
  • Product Description
    All VITEK® 2 AST Test Cards manufactured before 16 March 2017 are affected.Images with examples of a defective pouch together with a spreadsheets of lot numbers and expiry dates of affected products is listed both in the manufacturer’s Field Safety Notice and in the pdf file attached to this alert at the bottom of the page.
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux
  • Manufacturer Address
    Lena Duddell BioMérieux UK Limited Grafton House, Grafton Way Basingstoke, Hampshire RG22 6HY UKTelephone: 01256 461 881Email: lena.duddell@biomerieux.com
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    MHRA