BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3851529 · Received June 5, 2014

    Report

    Report Number
    1226181-2014-00303
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). TSC INSTRUCTED THE CUSTOMER TO CLEAN THE DRAINS FOR REAGENT PROBES 1 AND 2 AND SAMPLE PROBE 1, REPLACE SAMPLE PROBE 1, AND REPLACE THE DRYER BOOTS. PROBES WERE ALIGNED AND CLEANED WITH SODIUM HYDROXIDE AND REAGENT PROBES 1 AND 2 AND SAMPLE 1 PROBE PUMPS WERE PRIMED BY THE TSC REMOTELY. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED THE SAMPLE PROBE 1 MIXER DUE TO NUMEROUS FAILURES DURING THE UNDERMIX TESTING. THE CAUSE OF THE DISCORDANT, FALSELY LOW MAGNESIUM RESULTS IS A SAMPLE PROBE 1 MIXER MALFUNCTION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW MAGNESIUM RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). PATIENT SAMPLE (B)(6) WAS AUTO-REPEATED ON THE SAME INSTRUMENT, RESULTING AS EXPECTED AND THIS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN RERUN ON THE SAME INSTRUMENT SEVEN TIMES, RESULTING FALSELY LOW. THE SAMPLE WAS REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING AS EXPECTED. PATIENT SAMPLE (B)(6) WAS AUTO-REPEATED ON THE SAME INSTRUMENT, RESULTING LOW. THE SAMPLE WAS THEN RERUN ON THE SAME INSTRUMENT SEVEN TIMES, RESULTING FALSELY LOW ON ALL BUT ONE REPLICATE. THE SAMPLE WAS REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING AS EXPECTED AND REPORTED. PATIENT SAMPLE (B)(6) WAS AUTO-REPEATED ON THE SAME INSTRUMENT AND REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING AS EXPECTED ON BOTH AND REPORTED. PATIENT SAMPLE (B)(6) WAS AUTO-REPEATED, RESULTING FALSELY LOW. THE SAMPLE WAS REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING AS EXPECTED AND REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW MAGNESIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328670 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1