BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2219033 · Received July 21, 2011

    Report

    Report Number
    9610824-2011-00093
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    PMA / PMN Number
    125207-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED FALSE NEGATIVE REACTIONS OF A D POSITIVE CONTROL SAMPLE WITH CELL 1 OF BIOTESTCELL 3. WE RECEIVED THE COMPLAINED LOT OF BIOTESTCELL 3 BUT NOT THE CUSTOMER'S CONTROL SAMPLE. TESTING OF THE COMPLAINED BIOTESTCELL 3 LOT CONFIRMED WEAK POSITIVE AND UNCLEAR REACTIONS OF DIFFERENT ANTI-D SAMPLES WITH CELL 1 OF BIOTESTCELL 3 IN THE TUBE TECHNIQUE. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT. DUE TO THE CONFIRMED COMPLAINT A RISK ANALYSIS WAS PERFORMED. ON THE BASIS OF THE RESULT OF THAT RISK ANALYSIS WE DECIDED THAT NO MARKET RELATED ACTIVITIES ARE NECESSARY. A CAPA HAS BEEN INITIATED TO INTENSIFY THE EFFORTS TO FIND THE ROOT CAUSE FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL 3 BIOTESTCELL 3 LKJ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8123011

    Patients

    Seq Age Sex Outcome Treatment
    1 MLB2 (B)(4), LOT 8046070, EXP. 11/07/2012| AHG IGG SOLIDSCREEN II ((B)(4)), LOT 7039091-04| EXP. 09/15/2013