BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® XPAND PLUS WITH HM

    MDR report key: 3093052 · Received May 3, 2013

    Report

    Report Number
    1226181-2013-00202
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND INSTRUMENT DATA AND DETERMINED THAT THE CAUSE OF THE DISCORDANT CALCIUM RESULT WAS UNKNOWN. THE FSE PERFORMED MAINTENANCE ON THE INSTRUMENT, REPLACED REAGENT 1 PROBE, ALIGNED THE REAGENT 2 PROBE AND CHANGED THE CUVETTE DIAPHRAGM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT CALCIUM (CA) RESULT WAS OBTAINED ON A DIMENSION XPAND PLUS WITH HM SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT CALCIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193850 DIMENSION® XPAND PLUS WITH HM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD DIMENSION® XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1