BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 9 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100

    MDR report key: 11140000 · Received January 8, 2021

    Report

    Report Number
    1125230-2017-00017
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    January 8, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K983952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT CO20-2100-395: WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCHES. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. THE COMPLAINT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER STATES ISSUES WITH K+'S RUNNING HIGH ON COBAS INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34223 VACUETTE TUBE 9 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100 EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 455010P B170836R, B17023A9

    Patients

    Seq Age Sex Outcome Treatment
    1