BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN (RABBIT, POLYCLONAL)

    MDR report key: 2049646 · Received March 17, 2011

    Report

    Report Number
    9610824-2011-00029
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED A FALSE NEGATIVE REACTION OF SAMPLE A CONTAINING AN ANTI-E AND OF SAMPLE B CONTAINING AN ANTI-JK (A) WITH ANTI-HUMAN GLOBULIN, ANTI-IGG SOLIDSCREEN II. CUSTOMER HAS SENT US THE TWO MISSED ANTIBODIES BUT NOT THE COMPLAINED LOT OF ANTI-HUMAN GLOBULIN, ANTI-IGG SOLIDSCREEN II. THE ANTIBODIES WERE TESTED WITH THE RETENTION SAMPLES OF AHG ON TANGO IN THE QUALITY CONTROL LABORATORY AND REACTED NEGATIVELY. FURTHERMORE THE ANTIBODIES WERE TESTED IN THE GEL METHOD: SAMPLE A REACTED POSITIVELY AND SAMPLE B NEGATIVELY. ADDITIONAL TESTS IN ENZYME AND PEG (POLYETHYLENE-GLYCOL) METHODS WERE PERFORMED. SAMPLE A (ANTI-E) REACTED POSITIVELY IN THE ENZYME TECHNIQUE ON TANGO. SAMPLE B (ANTI-JK (A)) REACTED WEAKLY POSITIVE ONLY IN THE PEG METHOD AND A JK (A) HOMOZYGOUS REAGENT RED BLOOD CELL. THE CORRECT FUNCTION OF THE AFFECTED LOT AHG, ANTI-IGG SOLIDSCREEN II WAS CONFIRMED BY TESTING DIFFERENT WEAK ANTIBODIES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN (RABBIT, POLYCLONAL) ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN LKJ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7016110-05

    Patients

    Seq Age Sex Outcome Treatment
    1 EXP. 10/16/2011| MLB2: ((B)(4)), LOT 7951111, EXP. 05/12/2011| BIOTESTCELL-I8: ((B)(4)), LOT 8101011| SOLIDSCREEN II PLATES: ((B)(4)), LOT 7943010| EXP. 02/22/2011