BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM COMPLEXITY MEDIA TEST KIT

    MDR report key: 11372055 · Received February 23, 2021

    Report

    Report Number
    MW5099562
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    February 18, 2021
    Report Date
    February 19, 2021
    Manufacturer
    IVQA
    Product Code
    JSE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IVQA'S MEDIUM COMPLEXITY MEDIA TEST KIT LOT # 200812, EXP: 08/31/2023 IS CONTAMINATED AND CAUSED MEDIA FILL SAMPLES SUBMITTED FOR ANALYSIS TO BECOME TURBID AND ALLOW GROWTH OF GRAM NEGATIVE ORGANISMS. ALL OF THE MEDIA FILL SAMPLES I SUBMITTED TO US MICROSOLUTIONS FAILED DUE TO THIS CONTAMINATION. I CONTACTED THE COMPANY (IVQA) AND THEY CONFIRMED THAT THE ABOVE LOT NUMBER HAD PROBLEMS AND THEY STATED THEY WERE SENDING ME 15 REPLACEMENT KITS OF A DIFFERENT LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266708 MEDIUM COMPLEXITY MEDIA TEST KIT CULTURE MEDIA, MULTIPLE BIOCHEMICAL TEST JSE IVQA 200812

    Patients

    Seq Age Sex Outcome Treatment
    1