BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURGISCREEN FOR GEL

    MDR report key: 2213109 · Received August 16, 2011

    Report

    Report Number
    2250051-2011-00206
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD WAS NOT ABLE TO PERFORM FURTHER TESTING DUE TO EXPIRATION OF PRODUCT. A REVIEW OF THE WW COMPLAINT DATABASE INDICATES THAT THERE WERE NO SIMILAR COMPLAINTS FOR FALSE NEGATIVE RESULTS WITH THIS LOT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE, LATER CONFIRMED TO HAVE PASSIVE ANTI-D, DID NOT REACT WITH VSS394. RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT PRESENTED 4 DAYS LATER, AND AT THAT TIME, AN ANTIBODY SCREEN WAS PERFORMED WITH A DIFFERENT LOT OF 0.8% SURGISCREEN CELLS. WEAK POSITIVE RESULTS WERE OBSERVED. CUSTOMER INDICATES THAT THE TECH HAD ALIQUOTED THE 0.8% SURGISCREEN INTO TUBES AND THE CELLS BECAME MIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SURGISCREEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VSS394

    Patients

    Seq Age Sex Outcome Treatment
    1