BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEST DIAGNOSABLE SAMPLER VIRAL TRANSPORT MEDIA

    MDR report key: 10378451 · Received August 6, 2020

    Report

    Report Number
    MW5095926
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 6, 2020
    Report Date
    August 4, 2020
    Manufacturer
    WUXI NEST BIOTECHNOLOGY CO., LTD.
    Product Code
    JSM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A LARGE SHIPMENT OF VIRAL TRANSPORT MEDIA DESIGNATED FOR COVID-19 SPECIMEN COLLECTIONS WAS FOUND TO BE CONTAMINATED WITH BACTERIA. A QUALITY PROBLEM WAS DISCOVERED WITH A LARGE SHIPMENT (56,000) OF VIRAL TRANSPORT MEDIA (VTM) THAT WAS RECENTLY PROVIDED (06/30/2020) TO THE (B)(6) LABORATORY BY FEMA FOR COVID -19 SPECIMEN COLLECTIONS. WHEN PERFORMING ROUTINE QUALITY ASSURANCE TESTING OF THIS PRODUCT THE (B)(6) LAB DETERMINED THAT MULTIPLE TUBES OF THE PRODUCT FROM VARIOUS RANDOMLY SELECTED BOXES IN THE SHIPMENT WERE CONTAMINATED WITH PSEUDOMONAS FLUORESCENS, STENOTROPHOMONAS MALTOPHILIA AND BREVUNDIMONAS DIMINUTA. WE HAVE REPORTED OUR FINDINGS TO HHS, FEMA AND TO THE PUBLIC HEALTH LABORATORY COMMUNITY VIA THE APIL LAB DIRECTORS LIST SERVE. THREE OTHER PUBLIC HEALTH LABORATORIES (B)(6) IN THE MID-ATLANTIC REGION HAVE ALSO REPORT BACTERIAL CONTAMINATION IN THE NEXT VTM PRODUCT THAT WAS PROVIDED TO THEM BY FEMA. USING CONTAMINATED VTM COULD COMPROMISE THE INTEGRITY OF CLINICAL SPECIMENS AFFECT THE RESULTS OF SARS-COV-2 RNA TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841281 NEST DIAGNOSABLE SAMPLER VIRAL TRANSPORT MEDIA CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM WUXI NEST BIOTECHNOLOGY CO., LTD. NA 060620 MB1

    Patients

    Seq Age Sex Outcome Treatment
    1