BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2840261 · Received April 20, 2012

    Report

    Report Number
    9610824-2012-00058
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    March 23, 2012
    Report Date
    April 20, 2012
    Manufacturer
    BIOD-RAD MED DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 COMPLAINED THAT SOME PT SAMPLES YIELDED WEAK FALSE POSITIVE REACTIONS WITH CELL #3 OF BIOTESTCELL 3. THREE PT SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS WERE SENT TO US FOR QUALITY CONTROL AND THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED AS WELL. OUR QUALITY CONTROL LAB RETESTED THE ALLEGEDLY DEFECTIVE SAMPLE OF BIOTESTCELL 3 WITH THE THREE PT SAMPLES USING THE 3-PHASE TUBE TECHNIQUE WITH INCUBATIONS AT ROOM TEMPERATURE AND 37 DEGREES CELSIUS. ALL REACTIONS WERE NEGATIVE. THE PT SAMPLES WERE ALSO TESTED USING THE GEL METHOD WITH ANTI-HUMAN GLOBULIN AND IN SOLIDSCREEN II ON TANGO. THE THREE PT SAMPLES REACTED IN BOTH METHODS NEGATIVELY, FURTHERMORE, THE SAMPLES WERE TESTED IN THE TUBE TECHNIQUE AT 4 DEGREES CELSIUS. WITH THIS METHOD ALL THREE SAMPLES REACTED POSITIVELY. SAMPLE THREE REACTED POSITIVELY ONLY WITH CELL #3 WHILE SAMPLE ONE AND TWO REACTED POSITIVELY WITH ALL THREE BIOTESTCELL 3 SCREENING CELLS. THE ALLEGEDLY DEFECTIVE SAMPLE BIOTESTCELL 3 WAS ALSO TESTED WITH DIFFERENT POSITIVE AND NEGATIVE CONTROLS AND SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LAB CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 3 FUNCTIONS CORRECTLY. OUR TESTS REVEALED COLD ANTIBODIES IN ALL THREE PT SAMPLES. 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 REAGENT RED BLOOD CELLS BIOTESTCELL 3 BIOTESTCELL 3, PRODUCT CODE: KSZ KSZ BIOD-RAD MED DIAGNOSTICS GMBH 8207011

    Patients

    Seq Age Sex Outcome Treatment
    1 MLB2, LOT 8131021, EXP. 07/30/2013| IMMUCOR PANEL, LOT 03454, EXP. 03/23/2012| AHG ANTI-IGG, LOT 8114100-05, EXP. 03/22/2014| IMMUCOR PANEL, LOT 05479, EXP. 04/06/2012