BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 4496185 · Received February 9, 2015

    Report

    Report Number
    1226181-2015-00080
    Event Type
    Malfunction
    Date Received
    February 9, 2015
    Date of Event
    January 15, 2015
    Report Date
    January 15, 2015
    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 CUSTOMER CARE CENTER (CCC). THE CUSTOMER REPEATED THE SAMPLE ON THE SAME INSTRUMENT, OBTAINING THE EXPECTED RESULT. THE CUSTOMER RAN QUALITY CONTROLS, WHICH RESULTED WITHIN RANGE. IT WAS DISCOVERED THAT THE CUSTOMER WAS CENTRIFUGING PATIENT SAMPLES OUTSIDE OF THE TUBE MANUFACTURER SPECIFICATIONS. THE CAUSE OF THE DISCORDANT, FALSELY LOW GLUCOSE RESULT IS UNKNOWN. THE CAUSE OF THE SAMPLE BEING CENTRIFUGED OUTSIDE OF TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW GLUCOSE RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED OUT AND WAS QUESTIONED BY A NURSE. THE NURSE PERFORMED REPEAT TESTING WITH A FINGER STICK AND THE RESULT WAS HIGHER. THE CUSTOMER REPEATED THE SAMPLE ON THE SAME INSTRUMENT, AND THE RESULT MATCHED THAT OF THE FINGER STICK TEST RESULT. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW GLUCOSE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91048 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1