BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOLIANCE RECOMBIPLASTIN

    MDR report key: 673266 · Received February 3, 2006

    Report

    Report Number
    2431530-2006-00001
    Event Type
    Other
    Date Received
    February 3, 2006
    Report Date
    February 3, 2006
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED THAT PATIENTS RECEIVING DAPTOMYCIN HAVE LONGER PT TIMES USING HEMOLIANCE RECOMBIPLASTIN WHEN COMPARED WITH OTHER REAGENTS. CONTROLS WERE WITHIN RANGE. THE PT RESULTS WERE HIGH WHEN THE CUSTOMER RAN A PATIENT ON THE ELECTRA 1800C COAGULATION ANALYZER USING HEMOLIANCE RECOMBIPLASTIN, BUT THE CUSTOMER THEN SENT THE PLASMA TO ANOTHER LAB WITHIN ONE HOUR AND THE PT TIME WAS SHORTER USING ALTERNATE METHODS. THE PATIENT'S FINAL TREATMENT WAS BASED ACCORDING TO THE OTHER LAB'S ALTERNATE METHODS. TO OUR KNOWLEDGE, THERE WAS NO CHANGE IN PATIENT TREATMENT OR ADVERSE EVENT ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOLIANCE RECOMBIPLASTIN PROTHROMBIN TIME TEST GJS INSTRUMENTATION LABORATORY CO. NA N0353410

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN