BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1 & 2

    MDR report key: 2220645 · Received July 10, 2011

    Report

    Report Number
    9610824-2011-00089
    Event Type
    Malfunction
    Date Received
    July 10, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    125207-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED REPEATED FALSE POSITIVE REACTIONS (2+) WITH THE CELL 2 OF BIOTESTCELL 1 AND 2, LOT 8119011. THE FOLLOWING ANTIBODY DIFFERENTIATION WITH BIO-RAD PANEL OR ORTHO CLINICAL DIAGNOSTICS PANEL WAS ALWAYS NEGATIVE. THE CUSTOMER WORKS WITH EDTA PLASMA, GEL CARD SYS FROM ORTHO AND A DILUTED CELL SUSPENSION OF 0.8%. DESPITE SEVERAL INQUIRIES, THE CUSTOMER COULD NOT PROVIDE A DATE OF EVENT. WE RECEIVED NEITHER AN AFFECTED SAMPLE NOR THE COMPLAINED LOT OF BIOTESTCELL 1 AND 2. THEREFORE, THE RETENTION SAMPLE OF BIOTESTCELL 1 AND 2 WAS TESTED WITH 12 EDTA PLASMA OF BLOOD DONORS WITHOUT KNOWN ANTIBODIES. BECAUSE THE ORTHO GEL CARD SYS WAS NOT AVAILABLE FOR OUR TESTING THE QC PERFORMED THEIR RE-TESTING ON THE BIO-RAD GEL CARD SYS. TESTING OF THE QC LAB CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED BIOTESTCELL 1 AND 2 LOT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT. WE HAD NO FURTHER COMPLAINTS RELATED TO THE AFFECTED LOT OF BIOTESTCELL 1 AND 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL 1 & 2 BIOTESTCELL 1 & 2 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8119011

    Patients

    Seq Age Sex Outcome Treatment
    1