BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    461289VIRAL TRANSPORT MEDIUM, 3 ML

    MDR report key: 10605718 · Received September 29, 2020

    Report

    Report Number
    MW5096938
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 11, 2020
    Report Date
    September 25, 2020
    Manufacturer
    HARDY DIAGNOSTICS
    Product Code
    JSM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CONTAMINATED VIRAL TRANSPORT MEDIA (VTM). HARDY DIAGNOSTICS VIRAL TRANSPORT MEDIUM, 3 ML REF: (B)(4), LOT #461289P, EXP 11-11-2020. MANUFACTURER CLAIMS: ROOM TEMPERATURE STORAGE BEFORE INOCULATION HAS BEEN VALIDATED FOR UP TO 30 DAYS. THE PRODUCT WAS STORED AT ROOM TEMPERATURE FOR LESS THAN 14 DAYS AND TWO VIALS APPEARED TO BE CONTAMINATED WITH FUNGUS; 1 VIAL HAD A FUNGUS BALL FLOATING IN THE LIQUID. THE OTHER VIAL'S LID HAD A BLACK FILM ON THE INSIDE OF THE LID. BOTH VIALS HAD TURNED COLOR FROM REDDISH TO YELLOW WHICH INDICATES MICROORGANISM CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065528 461289VIRAL TRANSPORT MEDIUM, 3 ML CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM HARDY DIAGNOSTICS 461289P
    1065529 VIRAL TRANSPORT MEDIUM, 3 ML CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM HARDY DIAGNOSTICS 461289P

    Patients

    Seq Age Sex Outcome Treatment
    1