BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2149028 · Received June 15, 2011

    Report

    Report Number
    9610824-2011-00081
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAD REPORTED POSITIVE REACTIONS OF FOUR SAMPLES AFTER SOLIDSCREEN II CONTROL WAS PERFORMED. FURTHER TESTINGS OF CUSTOMER CONFIRMED ONE CORRECT POSITIVE SAMPLE AND THREE FALSE POSITIVE SAMPLES. WE RECEIVED NEITHER THE SAMPLES NOR THE AFFECTED LOT OF ANTI-HUMAN GLOBULIN ANTI-IPG SOLIDSCREEN II. THEREFORE THE RETENTION SAMPLES OF THE AFFECTED LOTS WERE TESTED. WE ALSO PROCESSED SOLIDSCREEN II CONTROL AND ANTIBODY FREE SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DIDN'T OBSERVE ANY FALSE POSITIVE REACTIONS AFTER RUNNING THE POSITIVE CONTROL. THE TESTING QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE AFFECTED LOTS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT. SERVICE INTERVENTION ON TANGO OPTIMO WAS PERFORMED ON (B)(6) 2011. SEVERAL PARTS INCLUDING RIGHT PIPETTOR NEEDLE AND ACTIVE WASH KNF PUMP ON TANGO OPTIMO S/N (B)(4) WERE REPLACED. PERFORMANCE VERIFICATION USING THE SAMPLES IN QUESTION, REVIEW OF TANGO EVENTLOG LIST AND RESULTS REVEALED NO FURTHER OCCURRENCE OF THIS ISSUE.

    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 MLB 2: LOT 7036120, EXP. 8/28/2012| SOLIDSCREEN II STRIP: LOT 7046080, EXP. 11/11/2012| EXP. 2/25/2012| AHG ANTI-IGG SOLIDSCREEN II: LOT 7035091-05,