BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2559317 · Received May 4, 2012

    Report

    Report Number
    9610824-2012-00068
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    April 23, 2012
    Report Date
    May 4, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    WHEN TAKING THE COVERS OFF HER TANGO OPTIMO, THE CUSTOMER CUT HERSELF WITH THE BIO-RAD SIGN ON THE FRONT OF THE TANGO OPTIMO. THE CUSTOMER SAID THE SIGN HAS BEEN GLUED SEVERAL TIMES AND WILL NOT REMAIN GLUED. THIS SITE HAS ONE OF THE OLDER MODELS AND THE TANGO OPTIMO SIGN GOES ACROSS THE WHOLE TOP OF THE TANGO OPTIMO. THE CUSTOMER ALSO MENTIONED THE SIGN HAS BEEN UNGLUED AT THE CORNERS, ESPECIALLY THE LEFT CORNER, FOR MANY YEARS. THIS HAS NEVER BEEN REPORTED TO BMD. THE CUSTOMER WAS STANDING IN FRONT OF THE TANGO OPTIMO IN THE PROCESS OF GETTING READY TO REMOVE THE COVERS. THE CUSTOMER THEN REACHED ACROSS THE TANGO OPTIMO TO THE LEFT TO TURN THE ANALYZER OFF WHEN THE SHELVE OF HER LAB COAT WAS CAUGHT BY THE BIO-RAD SIGN CAUSING THE SCRATCH ON HER ARM. THE CUSTOMER SAID SHE WAS BLEEDING AFTER THE SCRATCH BUT SAID SHE WAS FINE. THE TANGO OPTIMO SIGN WAS NOW FIXED BY ONE OF OUR FIELD SERVICE ENGINEERS. THE REPORTED PROBLEM IS ASSOCIATED TO A COINCIDENCE OF SEVERAL ITEMS WITH A FOCUS ON COMMUNICATION BETWEEN CUSTOMER AND COMPANY AS WELL AS INSUFFICIENT MAINTENANCE OF THE DEVICE IN QUESTION. APPARENTLY THE CUSTOMER WAS WELL AWARE OF THE DETRIMENTAL CONDITION OF THE CASING OF THE TANGO OPTIMO IN QUESTION BUT NEVER CONSIDERED TO ESCALATE IT TO BIO-RAD. SINCE THERE ARE NO FURTHER COMPLAINTS ON IDENTICAL ISSUES FROM ANYWHERE ELSE, THE COMPLAINT WILL BE CLOSED AS A SINGLE-EVENT.

    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