BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3944949 · Received July 18, 2014

    Report

    Report Number
    1226181-2014-00389
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS CUSTOMER CARE CENTER (CCC) WAS CONTACTED BY THE CUSTOMER. AFTER INSTRUMENT DATA EVALUATION, THE CCC VERIFIED THAT THERE WAS NO INDICATION OF CALCIUM CONTAMINATION, WEAK SAMPLE MIXING OR REAGENT DELIVERY ISSUES. THE CAUSE OF THE DISCORDANT CALCIUM RESULT IS UNKNOWN. THE CUSTOMER SUCCESSFULLY REPEATED THE TEST, WHICH WAS PROCESSED FROM THE PRIMARY TUBE AND MANUALLY SUBMITTED TO THE INSTRUMENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW CALCIUM (CA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE PATIENT SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, WHICH RESULTED HIGHER. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421374 DIMENSION VISTA 1500 CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1