BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO BRAIN THROMBOPLASTIN

    MDR report key: 177283 · Received July 13, 1998

    Report

    Report Number
    2250051-1998-00090
    Event Type
    Malfunction
    Date Received
    July 13, 1998
    Date of Event
    January 12, 1998
    Report Date
    July 10, 1998
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    GFO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT OBT348 DID NOT RECONSTITUTE WELL AND WAS GIVING PROLONGED CLOTTING TIMES. IF QUALITY CONTROL TESTING IS NOT PROPERLY PERFORMED PRIOR TO USING A DISCOLORED VIAL OF OBT348 TO TEST PATIENT SAMPLES, ERRONEOUS PT CLOTTING TIMES AND/OR INR VALUES MAY BE REPORTED. THIS CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS COMPLAINT NUMBER, 98-00131-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO BRAIN THROMBOPLASTIN PROTHROMBIN TIME TEST GFO ORTHO-CLINICAL DIAGNOSTICS NA OBT348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other