BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 2894431 · Received January 3, 2013

    Report

    Report Number
    1226181-2013-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYSIS OF THE INSTRUMENT THE FSE DETERMINED THAT THE CAUSE OF THE DISCREPANT MAGNESIUM RESULT WAS A MALFUNCTION OF THE S1 METERING PUMP. THE FSE REMOVED AND REPLACED THE METERING PUMP THEN PRIMED THE SYSTEM. THE FSE ALSO PERFORMED A PHOTOMETER ALIGNMENT AND LAMP INTENSITY ADJUSTMENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A DISCORDANT LOW MAGNESIUM (MG) RESULT WAS GENERATED BY THE DIMENSION VISTA 1500 SYSTEM FOR A SINGLE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS RETESTED IN DUPLICATE AND YIELDED A RESULT WITHIN EXPECTATIONS. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT MAGNESIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3094 DIMENSION VISTA 1500 IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1