BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 3212070 · Received July 8, 2013

    Report

    Report Number
    1226181-2013-00307
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE CUSTOMER HAD REPLACED THE SAMPLE PROBE AND CLEANED THE SAMPLE DRAIN PRIOR TO REPEATING THE PATIENT SAMPLE AND OBTAINING THE SECOND DISCORDANT RESULT ON THE SAMPLE. THE CUSTOMER HAD ALSO RETESTED A SAMPLE FROM A DIFFERENT PATIENT, WHICH RESULTED AS EXPECTED. AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. THE TSC SPECIALIST DISCOVERED THAT THE CUSTOMER WAS NOT CENTRIFUGING PATIENT SAMPLES ACCORDING TO THE TUBE MANUFACTURER SPECIFICATIONS, AND INSTRUCTED THE CUSTOMER ABOUT PROPER SAMPLE HANDLING. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. THE CAUSE OF PATIENT SAMPLES BEING CENTRIFUGED OUTSIDE OF THE TUBE MANUFACTURER SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED TROPONIN RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION RXL MAX WITH HM INSTRUMENT. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS RERUN ON AN ALTERNATE INSTRUMENT AND RESULTED LOWER. THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER THEN PERFORMED TROUBLESHOOTING ON THE DIMENSION RXL MAX INSTRUMENT, THEN RERAN THE SAMPLE. THE SAMPLE RESULTED HIGHER THAN THE INITIAL DISCORDANT RESULT. IT IS UNKNOWN IF THE SECOND DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311172 DIMENSION RXL MAX WITH HM CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1