BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID SALMONELLA AGAR

    MDR report key: 10028255 · Received May 6, 2020

    Report

    Report Number
    9615755-2020-00007
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Report Date
    August 5, 2020
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JWX
    UDI-DI
    03573026118877
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN AUSTRIA REGARDING ATYPICAL COLORATION WHEN TESTING A SALMONELLA STRAIN WITH CHROMID SALMONELLA - REFERENCE (B)(6), LOT 1007807000, EXPIRY DATE 22-MAY-2020. AN INTERNAL INVESTIGATION WAS CONDUCTED USING BIOMERIEUX RETAINED SAMPLES OF THE SUBJECT LOT, AND ON THE PLATES RECEIVED FROM THE CUSTOMER. THE TESTING RESULTS CONFIRMED THE PRODUCT PERFORMED WITHIN EXPECTED SPECIFICATIONS. THE CUSTOMER ISSUE WAS NOT REPRODUCED THROUGH THE INTERNAL INVESTIGATION PERFORMED ON THE RETAIN SAMPLES, NOR WITH THE CUSTOMERS PLATES PROVIDED. A ROOT CAUSE OF THE EVENT COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 1

    ON (B)(6) 2020, AN (B)(6) CUSTOMER REPORTED ATYPICAL COLORATION WHEN TESTING SALMONELLA STRAIN WITH CHROMID SALMONELLA 20 PLATES - REFERENCE 43621, LOT 1007807000, EXPIRY DATE 22-MAY-2020. THE CUSTOMER DIDN'T OBTAIN THE CORRECT CHARACTERISTIC COLONY COLOR ON 3 DIFFERENT SAMPLES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495097 CHROMID SALMONELLA AGAR CHROMID SALMONELLA 20 PLATES - 43621 JWX BIOMÉRIEUX SA 1007807000 03573026118877

    Patients

    Seq Age Sex Outcome Treatment
    1