BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMERIEUX AST-GNPP VITEK 2

    MDR report key: 19373870 · Received May 21, 2024

    Report

    Report Number
    MW5155221
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 19, 2024
    Report Date
    May 17, 2024
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 3/18/2024 I EMAILED (B)(4) FROM BIOMÉRIEUX ASKING FOR A STATUS UPDATE ON OUR GN99 ORDER BECAUSE WHEN I CALLED CUSTOMER SERVICE, I WAS TOLD THAT THE CARDS WERE UNAVAILABLE. (B)(4) TALKED TO (B)(4) (FIELD SERVICE ENGINEER) TO TELL HER TO TELL ME THAT THE CARDS ARE ON HOLD UNTIL THE ACKNOWLEDGEMENT FORM IS RETURNED. I THEN WENT THROUGH THE NOTIFICATION AND REVIEWED ALL THE LOTS AND DETERMINED THAT WE HAVE NOT RECEIVED ANY OF THE AFFECTED LOTS. I RETURNED THE FORM AND I LET (B)(4) KNOW SO SHE COULD EXPEDITE OUR ORDER. ON APRIL 30TH THE FDA ANNOUNCED THEIR RECALL AND (B)(6) HAD THE MICRO TEAM LOOK TO SEE IF WE HAD RECEIVED ANY OF THE LOTS ON THE LIST. IT WAS DETERMINED THAT BIOMÉRIEUX CONTINUED TO SHIP AFFECTED LOTS WITHOUT NOTIFICATION THAT THEY WOULD STILL SEND OUT AFFECTED LOTS. (B)(6) DID A COMPLETE REVIEW OF ALL THE AFFECTED PATIENTS, AND IT WAS DETERMINED THAT THERE WERE 12 PATIENTS AND ONLY 4 RECEIVED CEFTRIAXONE. I CREATED A RULE IN THE VITEK 2 SOFTWARE TO SUPPRESS CEFTRIAXONE RESULTS OF 0.5, 1, AND 2 AND THE RULE WAS ACTIVE ON 5/1/2024. CORRECTED REPORTS WERE CALLED ON 5/1/2024 AND 5/2/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298998 BIOMERIEUX AST-GNPP VITEK 2 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BIOMERIEUX, INC. 6892799103

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female