BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2209595 · Received August 3, 2011

    Report

    Report Number
    9610824-2011-00097
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    PMA / PMN Number
    125207-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: THE 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 THE 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 THE COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED FALSE NEGATIVE REACTIONS OF A D POSITIVE CONTROL SAMPLE WITH CELL 1 OF BIOTESTCELL 3. CUSTOMER HAD SENT NEITHER THE COMPLAINED LOT OF BIOTESTCELL 3 NOR THE CONTROL.

    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 ORTHO CONFIDENCE KIT, LOT CNF785