BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 2922880 · Received January 18, 2013

    Report

    Report Number
    1226181-2013-00030
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SOLUTIONS CENTER (TSC). AFTER ANALYZING THE INSTRUMENT DATA, THE TSC DETERMINED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE TSC INSTRUCTED THE CUSTOMER TO PURGE THE ALIQUOT PROBE, CLEAN THE OUTSIDE OF THE ALIQUOT PROBE AND BLEACH THE ALIQUOT DRAIN. A SIEMENS HEALTHCARE DIAGNOSTICS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO ADDRESS POST-TROUBLESHOOTING SHORT SAMPLING ISSUES RELATED TO ALIQUOT REFRESH PUMP ERRORS ENCOUNTERED WHILE RUNNING QUALITY CONTROLS. THE FSE REPLACED THE QUALITY CONTROL SAMPLES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HIGH CREATININE, BLOOD-UREA-NITROGEN (BUN) AND CALCIUM (CA) WERE GENERATED BY THE DIMENSION VISTA 500 SYSTEM FOR A SINGLE PATIENT SAMPLE. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND THE PATIENT ADMITTED TO THE HOSPITAL FOR CONSULTATION. THE CUSTOMER RETESTED THE SAMPLE ON A DIFFERENT INSTRUMENT AND OBTAINED RESULTS WITHIN EXPECTATIONS. A CORRECTED REPORT WAS ISSUED FROM THE LABORATORY. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28453 DIMENSION VISTA 500 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1