BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG

    MDR report key: 2254835 · Received August 23, 2011

    Report

    Report Number
    9610824-2011-00107
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT THEY MISSED AN INCOMPATIBLE CROSSMATCH CAUSED BY ANTI-IGG ART#: (B)(4), LOT 7039091-04. CUSTOMER REPORTED THEY DETECTED ANTI-JK(A) AND ANTI-FY(A) BUT MISSED AN ANTI-E AND GOT THEREFORE AN TRANSFUSION REACTION. CUSTOMER SENT US THE PT SAMPLE, THE COMPLAINT SAMPLE ANTI-IGG AND THE ANTI-IGG OF A COMPETITOR. THE PT SAMPLE WAS TESTED WITH THE ALLEGEDLY DEFECTIVE ANTI-IGG IN PARALLEL TO THE COMPETITOR'S ANTI-IGG. BOTH REAGENTS SHOWED COMPLETELY IDENTICAL REACTIONS. FURTHER TESTS SHOWED THAT THE ADD'L ANTIBODY WAS NOT AN ANTI-E BUT ANTI-K. THIS ANTIBODY COULD BE IDENTIFIED UNAMBIGUOUSLY WITH THE COMPLAINT SAMPLE ANTI-IGG, TESTING OF QUALITY CONTROL LAB CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED ANTI-IGG LOT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE COMPLAINED LOT'S QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN ANTI-IGG AHG ANTI-IGG LKJ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7039091-04

    Patients

    Seq Age Sex Outcome Treatment
    1 IMMUCOR ANTI-IGG, LOT 704018-1| IMMUCOR LISS, LOT 7036120