BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 2944494 · Received February 5, 2013

    Report

    Report Number
    1226181-2013-00052
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SOLUTIONS CENTER (TSC). AFTER REVIEWING THE INSTRUMENT DATA AND INFORMATION PROVIDED, THE TSC DETERMINED THAT USER ERROR CAUSED THE EVENT. THE USER CENTRIFUGED THE SAMPLE USING A STAT SPIN METHOD WHICH IS NOT IN LINE WITH THE TUBE MANUFACTURERS' RECOMMENDATIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT HIGH CREATININE RESULT WAS GENERATED BY THE DIMENSION VISTA 1500 SYSTEM. A NEW SAMPLE WAS OBTAINED AND TESTED AND A RETEST OF THE INITIAL SAMPLE WAS PERFORMED. THE RESULTS OBTAINED WERE WITHIN EXPECTATIONS AND REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT CREATININE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48123 DIMENSION VISTA 1500 IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly