BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISM HCV

    MDR report key: 1102165 · Received August 7, 2008

    Report

    Report Number
    1415939-2008-00496
    Event Type
    Other
    Date Received
    August 7, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 11, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    PMA / PMN Number
    103762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVAL IS ANTICIPATED BUT NOT YET INITIATED; THEREFORE, THERE ARE NO RESULTS TO REPORT AND NO RESULTS TO SUPPORT A CONCLUSION. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A REPEATEDLY REACTIVE PRISM HCV RESULT ON A PLATELET PHERESIS DONOR WHO TESTED PRISM HCV NEGATIVE A WEEK LATER. THE DONOR HAS REGULARLY DONATED PLATELET PHERESIS UNITS SINCE OCTOBER 1991 (PREVIOUSLY DONATING 329 TIMES). THE TWO PLATELET PHERESIS PRODUCTS THAT WERE YIELDED FROM THE REACTIVE PRISM HCV RESULT WERE DISCARDED. THE PRISM HCV REACTIVE SPECIMEN (UNIT) AND THE PRISM HCV NEGATIVE SPECIMEN (UNIT) BOTH TESTED HCV NAT NONREACTIVE. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISM HCV CHLIA FOR THE DETECTION OF ANTI-HCV MZO ABBOTT LABORATORIES NA 63612M100

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR PRISM ANALYZER