BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL POOL

    MDR report key: 2791984 · Received October 16, 2012

    Report

    Report Number
    9610824-2012-00171
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 21, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE ANTIBODY SCREENING TESTS WITH BIOTESTCELL-POOL WHEN TESTING ON TANGO OPTIMO. THE CUSTOMER STATED THAT THE CELL BUTTONS WERE NOT TIGHT BUT HAD A HAZE SURROUNDING. OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR THE SUPPOSEDLY DEFECTIVE PRODUCT AND THE SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THERE IS NO INDICATION FOR AN INSTRUMENT MALFUNCTION OF THE AFFECTED TANGO OPTIMO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE ANTIBODY SCREENING TESTS WITH BIOTESTCELL-POOL WHEN TESTING ON TANGO OPTIMO. THE CUSTOMER STATED THAT THE CELL BUTTONS WERE NOT TIGHT BUT HAD A HAZE SURROUNDING. THE CUSTOMER HAS NEITHER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE WITH DIFFERENT POSITIVE AND NEGATIVE CONTROLS AND SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-POOL FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THERE IS NO INDICATION FOR AN INSTRUMENT MALFUNCTION OF THE AFFECTED TANGO OPTIMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL POOL BIOTESTCELL POOL KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8235011

    Patients

    Seq Age Sex Outcome Treatment
    1 AHG, LOT 8209090-02, EXP. 08/22/2013| TANGO OPTIMO, # (B)(4)| TANGO OPTIMO, # (B)(4)| SOLIDSCREEN II, LOT 8211150, EXP. 03/09/2014| SOLIDSCREEN II, LOT 8211150, EXP. 03/09/2014| AHG, LOT 8209090-02, EXP. 08/22/2013