BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2636721 · Received July 2, 2012

    Report

    Report Number
    9610824-2012-00103
    Event Type
    Malfunction
    Date Received
    July 2, 2012
    Date of Event
    June 4, 2012
    Report Date
    July 2, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 BIOTESTCELL 3: LOT 8219011, EXP. 06/26/2012| ANTI-HUMAN GLOBULIN: LOT 8132120-02, EXP. 02/03/13| MLB2: LOT 8114021, EXP. 09/26/2012