BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMACLONE ANTI-D (MONOCLONAL BLEND)

    MDR report key: 753038 · Received July 31, 2006

    Report

    Report Number
    1034569-2006-00073
    Event Type
    Malfunction
    Date Received
    July 31, 2006
    Date of Event
    July 6, 2006
    Report Date
    July 31, 2006
    Manufacturer
    GAMMA BIOLOGICALS, INC
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SAMPLES WERE NOT RETURNED FOR INVESTIGATION TESTING. PATIENT'S SAMPLE WAS SENT TO THE LAB IN 2006. THEY TYPED PATIENT AS O, AND RH NEGATIVE USING MOLECULAR TESTING AND STATED THAT THE PATIENT HAS THE CRAWFORD PHENOTYPE. EXPLAINED TO THE CUSTOMER THAT PART OF THE SPECIFIC PERFORMANCE CHARACTERISTICS IN THE PACKAGE INSERT STATES THAT: "CERTAIN RARE RED BLOOD CELLS THAT APPEAR TO BE D-NEGATIVE WITH OTHER ANTI-D REAGENTS WILL REACT UNEXPECTEDLY WITH THIS REAGENT. RED BLOOD CELLS OF THE CRAWFORD PHENOTYPE ARE AGGLUTINATED AT THE IMMEDIATE-SPIN TEST PHASE ARE USUALLY NONREACTIVE AT THE WEAK D PHASE."

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS (3+) AT THE IMMEDIATE SPIN (S) PHASE WITH GAMMACLONE ANTI-D, (MONCLONAL BLEND) WHEN TESTING A PREVIOUSLY TYPED RH NEGATIVE PATIENT. THE PATIENT WAS ORIGINALLY TYPED IN 1998 AS O, RH NEGATIVE AND RETURNED TO THE FACILITY IN 2003 AND WAS TYPED AS O, RH POSITIVE WITH GAMMACLONE ANTI-D, LOT NUMBER UNKNOWN. TESTING WAS PERFORMED USING THE TUBE METHOD. PATIENT NEXT, RETURNED TO THE FACILITY IN 2006. PATIENT WAS TYPED AT THAT TIME WITH GAMMACLONE ANTI-D AS O, RH POSITIVE WITH A NEGATIVE ANTIBODY SCREEN AND WAS TRANSFUSED WITH 2 UNITS OF O, RH POSITIVE RED BLOOD CELLS. PATIENT RETURNED THE NEXT MONTH, WAS AGAIN TYPED WITH GAMMACLONE, ANTI-D, LOT #DMB62-1 AS 0, RH POSITIVE WITH A NEGATIVE ANTIBODY SCREEN AND A POSTIVE DAT (3+). ANTI-D WAS IDENTIFIED IN THE ELUATE. PATIENT'S SERUM WAS CLEAR, NO HEMOLYSIS NOTED. A TRANSFUSION REACTION WAS NOT CALLED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMACLONE ANTI-D (MONOCLONAL BLEND) BLOOD GROUPING REAGENT KSZ GAMMA BIOLOGICALS, INC * DMB62-1

    Patients

    Seq Age Sex Outcome Treatment
    1 *