BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 3232802 · Received July 18, 2013

    Report

    Report Number
    1226181-2013-00322
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST INSTRUCTED THE CUSTOMER TO CLEAN THE REAGENT PROBE 1 (R1), REAGENT PROBE 2 (R2) AND SAMPLE PROBE 1 (S1) AND THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) DRAINS. THE CUSTOMER ALSO WAS INSTRUCTED TO REPLACE THE IMT PROBE, AUTOALIGN THE R1, R2, S1 PROBES AND IMT MODULE, PRIME THE CLEANER AND ALL PROBE PUMPS MULTIPLE TIMES AND PERFORM A SODIUM HYDROXIDE (NAOH) CLEAN ON THE R1 AND R2 PROBES. THE TSC INSTRUCTED THE CUSTOMER TO RUN ALL QUALITY CONTROLS AND THEN RUN TEN PATIENT SAMPLES. THE CAUSE OF THE DISCORDANT RESULTS IS UNKNOWN. SIEMENS IS STILL INVESTIGATING.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2013-00322 WAS FILED ON JULY 17, 2013. ADDITIONAL INFORMATION (08/23/13): DURING FOLLOW-UP WITH THE CUSTOMER, THE CUSTOMER CONFIRMED THAT THERE WERE NO FURTHER PROBLEMS WITH THE INSTRUMENT AFTER TROUBLESHOOTING WAS PERFORMED. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE THEN RERUN ON THE SAME INSTRUMENT FOR CALCIUM AND GLUCOSE AND ON ANOTHER ANALYZER FOR ALL ANALYTES. THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333026 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1