BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 120

    MDR report key: 3222877 · Received July 12, 2013

    Report

    Report Number
    2432235-2013-00320
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKL
    PMA / PMN Number
    K971998
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. AFTER EVALUATING THE INSTRUMENT, THE FSE DETERMINED THAT THE CAUSE FOR THE HEMOGLOBIN REAGENT LEAK WAS DUE TO A MALFUNCTION IN THE REAGENT PUMP MEMBRANE. THE FSE REPLACED THE REAGENT PUMP AND ELECTRICAL COMPONENTS AFFECTED BY THE LEAK. THE ANALYZER IS OPERATING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE ANALYZER IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HEMOGLOBIN REAGENT LEAKED OUT OF A REAGENT PUMP ON THE ADVIA 120 INSTRUMENT, CAUSING AN ELECTRICAL SHORT THAT AFFECTED POWER TO THE CUSTOMER LAB. THERE WERE NO INJURIES REPORTED, NO KNOWN REPORTS OF MEDICAL INTERVENTION OR ADVERSE HEALTH CONSEQUENCES AND NO KNOWN DELAY IN PATIENT TESTING DUE TO THE LEAKING REAGENT PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324449 ADVIA 120 HEMATOLOGY ANALYZER GKL SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 120

    Patients

    Seq Age Sex Outcome Treatment
    1