BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 2942442 · Received February 4, 2013

    Report

    Report Number
    1226181-2013-00049
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 10, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE FSE REPLACED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) PROBE, REAGENT 1 PROBE AND SAMPLE 1 PROBE. THE PROBES WERE ALIGNED AND QUALITY CONTROLS WERE RUN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT CALCIUM (CA) RESULT WAS GENERATED BY THE DIMENSION VISTA 1500 SYSTEM. THE SYSTEM PERFORMED AN AUTOMATIC RETEST OF THE SAMPLE AND YIELDED A RESULT WITHIN EXPECTATIONS. THE DISCORDANT RESULT WAS NOT RELEASED FROM THE LABORATORY. THE CUSTOMER RETESTED THE SAMPLE ON ANOTHER SYSTEM. THE RETEST RESULT WAS RELEASED FROM THE LABORATORY. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT CALCIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46742 DIMENSION VISTA 1500 IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1