BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II

    MDR report key: 2526677 · Received October 9, 2009

    Report

    Report Number
    9610824-2009-00008
    Event Type
    Other
    Date Received
    October 9, 2009
    Date of Event
    September 4, 2009
    Report Date
    September 9, 2009
    Manufacturer
    BIOTEST AG
    Product Code
    DEW
    PMA / PMN Number
    125098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COULD SEND US NEITHER THE COMPLAINED ANTI-HUMAN-GLOBULIN NOR THE MISSED ANTIBODY. THE RETENTION SAMPLES OF THE AFFECTED LOTS WERE TESTED WITH A KNOWN ANTI-FYA ( A (B)(6) CONTROL REAGENT) AND REACTED CORRECTLY POSITIVE. WE CAN ONLY SPECULATE WHY THE FIRST PT SAMPLE DIDN¿T REACT POSITIVE BECAUSE WE DON¿T KNOW HOW THE SAMPLE WAS DRAWN AND WHAT WAS TRANSFUSED AT THE FIRST FACILITY RESPECTIVELY DURING THE TRANSFER OF THE PT (IT IS UNK WHETHER THE UNIT TRANSFUSED DURING PT TRANSFER WAS FYA POSITIVE OR NEGATIVE). THE REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES. THE TANGO OF THE CUSTOMER WAS EXAMINED AND TESTED WITH A SERIAL DILUTION OF SOLIDSCREEN II CONTROL. THE SERIAL DILUTION RESULT STRENGTH MATCHED THE ACCEPTANCE CRITERIA. THEREFORE WE CAN RULE OUT A MALFUNCTION OF TANGO AS THE CAUSE OF THE UNDETECTED ANTIBODY. THE CORRECT FUNCTION OF THE AFFECTED LOT ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II AND THE TANGO WAS CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT THEY MISSED AN ANTIBODY (ANTI-FYA) WITH ANTI-HUMAN GLOBULIN. INTESTINAL BLEED WAS ADMITTED TO A FACILITY. THIS FACILITY WAS NOT EQUIPPED TO HANDLE SUCH AN EMERGENT PT. ONE UNIT ¿EMERGENCY RELEASE¿ BLOOD (DONOR UNITS PROVIDED FOR TRANSFUSION BEFORE THE TYPE, SCREEN AND CROSS MATCH TESTING IS COMPLETE, THEY MAY BE TYPE SPECIFIC FOR BLOODGROUP O) WAS PROVIDED FOR TRANSFUSION AND THE PT WAS TRANSFERRED TO ANOTHER FACILITY. WHEN THE PT ARRIVED THERE A SPECIMEN WAS DRAWN AND ANTIBODY SCREENING TEST WAS PERFORMED WITH SOLIDSCREEN II ON TANGO. THE SCREENING TEST WAS NEGATIVE. THE PT WAS TRANSFUSED THREE UNITS. ON (B)(6) 2009, A TRANSFUSION REACTION WAS SUSPECTED. THE DAT (DIRECT ANTI-HUMAN-GLOBULIN TEST) WAS WEAKLY POSITIVE ON A POST-REACTION SAMPLE. ON (B)(6) 2009, A ROUTINE SAMPLE OF PT WAS DRAWN. THIS SAMPLE WAS TESTED IN SOLIDSCREEN II ON TANGO AND REACTED POSITIVELY. THE CUSTOMER COULD NOT PROVIDE NEITHER THE PT SAMPLE (THE ANTIBODY NOT DETECTED) NOR THE COMPLAINT SAMPLE. THEREFORE IN THE QUALITY CONTROL LAB RETENTION SAMPLES OF ALL AFFECTED LOTS WERE TESTED IN SOLIDSCREEN II ON TANGO WITH A KNOWN ANTI-FYA AND A (B)(6) CONTROL REAGENT OF (B)(6). THIS ANTI-FYA REACTED CORRECTLY POSITIVE WITH OUR REAGENTS. THERE IS NO EVIDENCE THAT THE REAGENT DIDN¿T REACT CORRECTLY, BECAUSE ALSO ON CUSTOMER¿S SIDE THERE WAS A CORRECT POSITIVE REACTION ON THE SAMPLE DRAWN ON (B)(6). (B)(6) INVESTIGATION RESULTS: THE ANTIBODY DETECTED ON (B)(6), WAS AN ANTI-FYA, DETECTED BOTH ON TANGO AND IN ORTHO GEL. TWO OF THE 3 UNITS TRANSFUSED WERE FYA ANTIGEN POSITIVE. THE SAMPLE DRAWN BY THE ORIGINAL FACILITY ON SEPT. 4 WAS TESTED POSITIVE IN ORTHO GEL (ANTIBODY = ANTI-FYA). RETESTING OF THE SAMPLE GAVE A WEAK POSITIVE RESULT IN GEL. BUT THE CROSSMATCH TO THE FYA POSITIVE DONOR UNITS IN GEL TECHNIQUE WAS NEGATIVE AND THEREFORE COMPATIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II AHG SOLIDSCREEN II DEW BIOTEST AG 77841090-02

    Patients

    Seq Age Sex Outcome Treatment
    1