BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 3140582 · Received May 31, 2013

    Report

    Report Number
    1226181-2013-00251
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    DHA
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE TSC SPECIALIST PERFORMED TROUBLESHOOTING WITH THE CUSTOMER. THE CUSTOMER RERAN ALL OTHER PATIENT SAMPLES FROM THAT DAY AND ALL RESULTED THE SAME UPON REPEAT AS THE INITIAL RUN. THE CAUSE OF THE DISCORDANT, FALSE NEGATIVE HCG RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSE NEGATIVE HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND RESULTED HIGHER. THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE NEGATIVE HCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240945 DIMENSION XPAND PLUS WITH HM CLINICAL CHEMISTRY ANALYZER DHA SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION XPAND PLUS W/HM

    Patients

    Seq Age Sex Outcome Treatment
    1