BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 3760150 · Received April 18, 2014

    Report

    Report Number
    1226181-2014-00212
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. AFTER EVALUATION, THE CSE DETERMINED THAT THE CUSTOMER WAS RUNNING THE INSTRUMENT WITH FAILED DILUENT CHECK, A NON-STANDARD USE OF THE DILUENT CHECK PRODUCT. THE DILUENT CHECK PRODUCT INTENDED USE STATEMENT, SPECIFIES DILUENT CHECK IS USED TO MONITOR AND ADJUST FOR THE DILUTION RATION ON THE DIMENSION CLINICAL CHEMISTRY SYSTEM, THE QUIKLYTE®. THE CSE PROACTIVELY REPLACED ALL (IMT) TUBING, PORT AND VALVE ASSEMBLY, ROTARY VALVE AND RESET THE DILUENT CHECK TO 1.00. THE CAUSE OF THE NON-STANDARD USE OF DILUENT CHECK ON THE SYSTEM WAS THE USER NOT FOLLOWING THE PROPER DILUENT CHECK PRODUCT INSTRUCTIONS. THE CSE SUCCESSFULLY RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER WAS OBTAINING INTEGRATED MULTISENSOR TECHNOLOGY (IMT) DILUENT CHECK ERRORS ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT. THE DILUENT CHECK FACTOR THE CUSTOMER USED WAS 1.034. THE TYPICAL DILUENT CHECK FACTOR USED ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT IS 1.00 -1.02. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER NOT USING THE CORRECT DILUENT CHECK FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237101 DIMENSION XPAND PLUS WITH HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1