BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA PEG

    MDR report key: 1417048 · Received July 21, 2009

    Report

    Report Number
    1034569-2009-00247
    Event Type
    Malfunction
    Date Received
    July 21, 2009
    Date of Event
    June 23, 2009
    Report Date
    July 17, 2009
    Manufacturer
    IMMUCOR, INC
    Product Code
    KSG
    PMA / PMN Number
    BK910001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH CUSTOMER'S RETURNED PATIENT SAMPLE USING RETENTION PANOSCREEN I, II, AND III, LOT 20442. RETENTION PEG, LOTS 336011 AND 336012, WERE USED AS POTENTIATORS. SAMPLE EXHIBITED WEAK REACTIVITY (1+) WITH D-POSITIVE CELLS AND WAS NONREACTIVE WITH D-NEGATIVE CELL.HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH 2 ADDITIONAL RETURNED PATIENT SAMPLES, USING D-POSITIVE, FY(A-), JK(A-) CELL 3 AND D-NEGATIVE, FY(A-), JK(A-) CELL 16 FROM RETENTION PANOCELL-20, LOT 21467. RETENTION PEG, LOTS 336011 AND 336012, WERE USED AS POTENTIATORS. BOTH SAMPLES EXHIBITED WEAK REACTIVITY (1+) WITH D-POSITIVE CELL AND WERE NONREACTIVE WITH D-NEGATIVE CELL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WHEN TETING PATIENTS WITH ANTI-D WHEN USING GAMMA PEG. IT IS NOT HELPING THE DETECTION OF WEAKLY REACTIVE ANTI-D ANTIBODIES, SUCH AS RH IMMUNE GLOBULIN IN PATIENT SAMPLES. THE CUSTOMER ALSO HAD A PATIENT WHO SEEMS TO HAVE ANTI-D REACTING WELL IN GEL (4+) BUT NOT AT ALL USING PEG. PATIENT NEVER RECEIVED UNSUITABLE UNITS FOR TRANSFUSION.CUSTOMER IS NOT HAVING PROBLEMS PICKING UP OTHER THAN ANTI-D ANTIBODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA PEG ANTIBODY POTENTIATING REAGENT KSG IMMUCOR, INC 336012

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR