BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 3183632 · Received June 22, 2013

    Report

    Report Number
    1226181-2013-00277
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CUSTOMER RAN A PRECISION TEST, AND THE PRECISION RESULTS WERE NOT WITHIN SPECIFICATIONS. THE TSC SPECIALIST ADVISED THE CUSTOMER TO REPLACE THE SAMPLE PROBE, REAGENT PROBE 1, AND WASH 1 BS PROBE. THE CUSTOMER DID SO, AND THEN RAN A SYSTEM DECONTAMINATION AND CLEANED THE DRAINS. PRECISION WAS RUN AGAIN, AND RESULTED WITHIN SPECIFICATIONS. THE CAUSE OF THE DISCORDANT, FALSELY LOW TROPONIN 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, FALSELY LOW TROPONIN RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE HAD RESULTED HIGHER DURING AN INITIAL RUN. THE SAMPLE WAS RERUN IN DUPLICATE ON THE SAME INSTRUMENT, AND ONE REPLICATE RESULTED LOW WHILE THE OTHER REPLICATE ALIGNED WITH THE INITIAL RESULT. THE INITIAL RESULT WAS THEN REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW TROPONIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284424 DIMENSION XPAND PLUS WITH HM CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1