BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2970088 · Received February 20, 2013

    Report

    Report Number
    1226181-2013-00080
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DECIDED TO RUN ALIGNMENT METHODS. THE FSE THEN ADJUSTED THE BOTTOM OF CUVETTE FOR THE SAMPLE 3 POSITION. THE CUSTOMER RAN QUALITY CONTROLS, WHICH WERE WITHIN RANGE, AND PATIENT SAMPLES, WHICH WERE ACCURATE. THE CAUSE OF THE DISCORDANT, FALSELY LOW CALCIUM RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW CALCIUM RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE FIRST LOW CALCIUM RESULT WAS FLAGGED BY THE INSTRUMENT, BUT THE SECOND RESULT WAS NOT. THE SAMPLES WERE RERUN AN ALTERNATE DIMENSION VISTA 1500 INSTRUMENT, AND HIGHER RESULTS WERE OBTAINED. IT IS UNKNOWN IF THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CALCIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73008 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1