BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM 5000 SENSOR AND REAGENT CARTRIDGE

    MDR report key: 14753662 · Received June 21, 2022

    Report

    Report Number
    1217183-2022-00003
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    May 23, 2022
    Report Date
    June 21, 2022
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    UDI-DI
    08426950807810
    PMA / PMN Number
    K203790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSTRUMENTATION LABORATORY CONDUCTED AN INVESTIGATION THAT INCLUDED A REVIEW OF THE CUSTOMER-PROVIDED PHOTOGRAPHS DEMONSTRATING SMALL AMOUNTS OF MOLD ON THE GEM 5000 SENSOR AND REAGENT CARTRIDGE. THIS EVENT MAY HAVE OCCURRED DUE TO A POSSIBLY BROKEN OR INCOMPLETE SEAL OF AN INTERNAL REAGENT BAG. EXPOSURE TO ENVIRONMENTAL MOLDS CAN CAUSE LOCAL SKIN, EYE, OR MUCOSAL MEMBRANE IRRITATION. STANDARD LABORATORY PRACTICE IS TO HANDLE ALL REAGENTS/CARTRIDGES WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT, THUS LIMITING EXPOSURE TO MOLD OR OTHER CONTAMINANTS. THUS, IT IS IMPROBABLE THAT HARM WOULD OCCUR DUE TO THE EVENT. NO REMEDIAL ACTION IS REQUIRED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A COMPLAINT INDICATING A GEM 5000 SENSOR AND REAGENT CARTRIDGE WAS RECEIVED WITH MOLD ON IT. THE CUSTOMER REPORTS UPON OPENING THE PACKAGING, MOLD WAS OBSERVED ON THE EXTERIOR OF THE CARTRIDGE CASE AND/OR LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349596 GEM 5000 SENSOR AND REAGENT CARTRIDGE 5K BG/ISE/GL/COOX 450 TEST PAK 31D CHL INSTRUMENTATION LABORATORY CO. 00055445010 220318C 08426950807810

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other