BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1 & 2

    MDR report key: 2070590 · Received April 7, 2011

    Report

    Report Number
    9610824-2011-00042
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STN#: 125207-08.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A KNOWN ANTIBODY POSITIVE PATIENT WITH BIOTESTCELL 1 AND 2. THE PATIENT WAS SUPPOSED TO HAVE ANTI-K, ANTI-E AND ANTI-C. CUSTOMER PROCESSED SAMPLE ON ANOTHER TANGO ON HIS SITE AND RECEIVED THE EXPECTED POSITIVE REACTION. CUSTOMER SENT US THE PATIENT SAMPLE BUT NOT THE COMPLAINED LOT OF BIOTESTCELL 1 AND 2. WE RECEIVED TWO SAMPLES FROM THE SAME PATIENT BUT DRAWN AT DIFFERENT DATES. THE SAMPLES WERE TESTED ON TANGO WITH THE BIOTESTCELL 1 AND 2 RETENTION SAMPLE AND REACTED BOTH TIMES CORRECTLY POSITIVE. DURING A SERVICE INTERVENTION ON THE TANGO INSTRUMENT WHICH HAD SHOWN THE FALSE NEGATIVE RESULT, THE 8-CHANNEL VALVE HEAD WAS REPLACED. AFTER THAT REPLACEMENT THE SAMPLE WAS TESTED AGAIN AND REACTED CORRECTLY POSITIVE.

    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 8107011

    Patients

    Seq Age Sex Outcome Treatment
    1 AHG ANTI-IGG SSC II: LOT 7035090-02| SOLIDSCREEN II STRIP: LOT 7028010| MLB2: LOT 7036120, EXP. 08/28/2012| EXP. 02/25/2012| EXP. 07/08/2012