BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG

    MDR report key: 3232344 · Received December 21, 2012

    Report

    Report Number
    9610824-2012-00215
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    September 12, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BIOTEST AG
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE FAILED CAP J-C 2012 COMPREHENSIVE IMMUNOHEMATOLOGY SURVEY FOR CROSSMATCH OF J-15 S WITH J-20 R. THE CUSTOMER HAS NEITHER RETURNED THE CAP SURVEY SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS NOR THE SUPPOSEDLY DEFECTIVE PRODUCT. OUR QUALITY CONTROL LAB HAD ALSO PARTICIPATED IN THE CAP SURVEY TESTING, BUT WAS USED FOR CROSSMATCH TESTING ANTI-HEMOGLOBULIN, ANTI-IGG, C3D; POLYSPECIFIC. THE CROSSMATCH YIELDED A 4+ POSITIVE REACTION. FURTHERMORE THE RETAINED SAMPLE WAS TESTED WITH POSITIVE AND NEGATIVE CONTROLS AND SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LAB CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF ANTI-HUMAN-GLOBULIN ANTI-IGG FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN ANTI-IGG AHG ANTI-IGG KSZ BIOTEST AG 8135080-03

    Patients

    Seq Age Sex Outcome Treatment
    1