BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 5776371 · Received July 7, 2016

    Report

    Report Number
    1226181-2016-00361
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    June 16, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND STATED THAT THEY OBTAINED DISCORDANT RESULTS AFTER THE "PROGARD" WAS INSTALLED IN PLACE OF "Q-GARD". THE CUSTOMER RAN QUALITY CONTROLS (QC), WHICH WERE OUT OF RANGE. THE CUSTOMER PLACED THE Q-GARD FILTER IN THE CORRECT SLOT. THE CUSTOMER EMPTIED AND FILLED THE WATER TANK TWO TIMES AND RAN QC, WHICH WERE WITHIN RANGE. THE CUSTOMER RERAN BOTH SAMPLES AND OBTAINED RESULTS AS EXPECTED. THE CUSTOMER INSTALLING PROGARD IN PLACE OF Q-GARD IS A USER ERROR. THE CAUSE OF THE DISCORDANT, FALSELY DEPRESSED CA RESULTS ON TWO PATIENT SAMPLES WAS DUE TO USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY DEPRESSED CALCIUM (CA) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED CA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428602 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1