BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2970087 · Received February 20, 2013

    Report

    Report Number
    1226181-2013-00081
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATING THE INSTRUMENT DATA, THE TSC SPECIALIST DID NOT FIND ANY INSTRUMENT MALFUNCTION. THE CUSTOMER STATED THAT THE RERUN RESULT CORRELATED WITH THE CLINICAL PICTURE OF THE PATIENT, AND THAT OTHER TESTS WERE BEING RUN ON THE INSTRUMENT FOR WHICH THERE HAD NOT BEEN ANY OTHER DISCORDANT RESULTS. THE CAUSE OF THE DISCORDANT, FALSELY LOW CREATININE RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW CREATININE RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN MULTIPLE TIMES, AND THE RERUN RESULTS WERE HIGHER. IT IS UNKNOWN IF THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CREATININE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73849 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1