BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2003153 · Received February 3, 2011

    Report

    Report Number
    9610824-2011-00010
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 1, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF ONE PT SAMPLE WITH CELL 2 OF BIOTESTCELL 3. CUSTOMER SENT US THE COMPLAINED REAGENT RED BLOOD CELLS BIOTESTCELL 3 AND THE PT SAMPLE. BOTH WERE TESTED ON TANGO IN THE QUALITY CONTROL LABORATORY. WE CAN CONFIRM A WEAK POSITIVE REACTION WITH CELL 2 OF BIOTESTCELL 3. ADDITIONALLY WE TESTED SEVERAL CONTROLS ON TANGO: ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE OBSERVED NO FALSE POSITIVE REACTIONS. FURTHERMORE THE AFFECTED PT SAMPLE WILL BE TESTED IN DIFFERENT METHODS. WE WILL TRY TO IDENTIFY AN ANTIBODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL 3 BIOTESTCELL 3 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7047021

    Patients

    Seq Age Sex Outcome Treatment
    1 AHG ANTI-IGG SOLIDSCREEN II (B)(4)| MLB2 (B)(4): LOT 7013110| LOT 7949130-04| SOLIDSCREEN II PLATE (B)(4), LOT 7023030