BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® XPAND PLUS WITH HM

    MDR report key: 2912136 · Received January 11, 2013

    Report

    Report Number
    1226181-2013-00014
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD
    Product Code
    MSK
    PMA / PMN Number
    K010061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT, THE FSE DETERMINED THAT THE CAUSE OF THIS EVENT IS NOT KNOWN. THE FSE REMOVED AND CLEANED THE INCUBATION AND WASH WHEELS, REPLACED THE HETEROGENEOUS MODULE (HM) TUBING HARNESS AND CALIBRATED THE HM MIXERS. QUALITY CONTROLS WERE RUN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    LOW TACROLIMUS (TACR) QUALITY CONTROL AND PATIENT RESULTS, COMPARED TO RESULTS THREE DAYS PRIOR, WERE GENERATED BY THE DIMENSION XPAND PLUS WITH HM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE NOT RETESTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE LOW RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16294 DIMENSION® XPAND PLUS WITH HM CLINICAL CHEMISTRY SYSTEM MSK SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD DIMENSION® XPAND PLUS WITH HM NA

    Patients

    Seq Age Sex Outcome Treatment
    1