BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2902877 · Received January 9, 2013

    Report

    Report Number
    9610824-2012-00202
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 18, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969961696
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13307 TANGO OPTIMO AUTOMATED BLOOD BANK ANALYSER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 07611969961696

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ANTI-HUMAN-GLOBULIN, LOT 8209090-03, EXP. 08/22/13| BIOTESTCELL 3, LOT 8243011, EXP. 12/11/2012| BIOTESTCELL-I11, LOT 8241011, EXP. 11/27/2012| SOLIDSCREEN II, LOT 8215040, EXP. 04/06/2014