BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2276487 · Received September 30, 2011

    Report

    Report Number
    9610824-2011-00140
    Event Type
    Malfunction
    Date Received
    September 30, 2011
    Date of Event
    January 26, 2011
    Report Date
    September 30, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITI ON HAND IS PART OF A SERIES OF COMPLAINTS WITH DELAYED REPORTING TO THE AUTHORITIES. ALL OF THESE CASES WILL INDIVIDUALLY BE INVESTIGATED AND PROCESSED BUT WILL COLLECTIVELY INDUCE A CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT TWO SAMPLES YIELDED FALSE POSITIVE REACTIONS WITH BIOTESTCELL 3. ANOTHER SAMPLE WITH SAME LOT WAS WEAK TO RARE 2+ IN SCREEN AND PANEL, ALL NEGATIVE AT A REFERENCE LAB. WHEN THE CASE WAS DISCOVERED DURING EFFICIENCY CHECK OF CAPA (B)(4) IT WAS EVALUATED TO BE MDR RELEVANT BY BMD ITS BECAUSE OF THE INITIAL DESCRIPTION OF THE CUSTOMER. HOWEVER, THE CUSTOMER INFORMED BIO-RAD WITHIN THE FIRST PHONE CALL IN APRIL NOT TO BE INTERESTED IN A FORMAL COMPLAINT WORK-UP, BECAUSE, THERE IS NOT ENOUGH INFO TO DO SO. THE CUSTOMER DID NOT WISH TO HAVE THE TANGO SERVICED. HE ALSO HAD SENT NEITHER THE AFFECTED SAMPLES NOR THE COMPLAINED BIOTESTCELL 3 PRODUCT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANGO OPTIMO AUTOMATED BLOOD BANK ANALYZER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 BIOTESTCELL 3: LOT# 7051011, EXP: 02/08/2011