BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 3306158 · Received August 23, 2013

    Report

    Report Number
    1226181-2013-00367
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Date of Event
    July 31, 2013
    Report Date
    July 31, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTION CENTER (TSC). TSC ASSISTED THE CUSTOMER IN ALIGNMENT OF THE SAMPLE 1 AND REAGENT 1 PROBE. UPON FOLLOW UP, THE CUSTOMER STATED THAT NO ADDITIONAL DISCORDANT CALCIUM RESULTS WERE OBTAINED. THE CAUSE OF THE INCONSISTENT CALCIUM RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2013-00367 WAS FILED ON AUGUST 23, 2013. ADDITIONAL INFORMATION (08/23/2013): A CORRECT RESULT OF 9.1 WAS REPORTED TO THE PHYSICIAN(S).

    Description of Event or Problem · 1

    INCONSISTENT CALCIUM RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCONSISTENT CALCIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414905 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1