BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2915503 · Received January 15, 2013

    Report

    Report Number
    1226181-2013-00026
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER ANALYZING THE INSTRUMENT DATA, THE TSC DETERMINED THAT THE CAUSE OF THE DISCORDANT RESULT WAS PROBE ALIGNMENT. THE TSC INSTRUCTED THE OPERATOR TO PRIME, CLEAN AND ALIGN THE PROBES, AND PRIME THE PUMPS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT CALCIUM RESULT WAS OBTAINED ON THE VISTA 500 INSTRUMENT. THE INSTRUMENT FLAGGED THE DISCORDANT RESULT, AND AUTOMATICALLY RETESTED THE SAMPLE. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE CORRECTED CALCIUM RERUN RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21452 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1