BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3081724 · Received April 29, 2013

    Report

    Report Number
    1226181-2013-00188
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LEH
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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; INADEQUATE SAMPLE HANDLING. THE TSC REQUESTED THE CUSTOMER REPEAT THE SAMPLE AND PERFORM QC. THE TSC DETERMINED THAT THE INSTRUMENT PERFORMED WITHIN SPECIFICATION AND THERE WAS NO INSTRUMENT MALFUNCTION DURING THE TIME OF THE EVENT. 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
    184497 DIMENSION VISTA 1500 IMMUNOASSAY ANALYZER LEH SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1