BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3112666 · Received May 14, 2013

    Report

    Report Number
    1226181-2013-00217
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SUPPORT CENTER (TSC). AFTER THE TSC EVALUATED THE DATA, IT WAS DETERMINED THE CAUSE FOR THE DISCORDANT VANCOMYCIN RESULT WAS USER ERROR; SAMPLE INTEGRITY. THE TSC REVIEWED THE VANCOMYCIN QC FOR THE PAST 60 DAYS AND VERIFIED ACCEPTABLE PERFORMANCE WITH NO SIGNS OF ANY ASSAY OR INSTRUMENT HARDWARE ISSUES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT RESULT FOR VANCOMYCIN WAS OBTAINED ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE LOW RESULT. THE CUSTOMER RERAN THE SAME SAMPLE ON THE SAME INSTRUMENT AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VANCOMYCIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211909 DIMENSION VISTA 1500 IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1