BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 7834658 · Received August 30, 2018

    Report

    Report Number
    2517506-2018-00488
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    July 30, 2018
    Report Date
    November 30, 2018
    Manufacturer
    DIMENSION EXL WITH LM
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR ON 30-AUG-2018. ADDITIONAL INFORMATION (09-NOV-2018): SIEMENS FURTHER INVESTIGATED THE ISSUE. A REVIEW OF THE CLOT CHECK DATA SHOWED ATYPICAL ASPIRATIONS FOR THE SAMPLE, WHICH INDICATE THERE WAS AN ISSUE WITH THE ASPIRATION OF THE SAMPLE. SAMPLE INTEGRITY ISSUES SUCH AS HIGH SAMPLE VISCOSITY AND PARTICULATE MATTER (FIBRIN/ MICROCLOTS) OR A SAMPLE PROBE FUNCTION AND ALIGNMENT ISSUE POTENTIALLY CONTRIBUTED TO THE EVENT. THE SAMPLE PROBE FUNCTION WAS WITHIN REQUIREMENTS AND NO OTHER ISSUES WERE OBSERVED. THE CUSTOMER WAS NOT CENTRIFUGING THE SAMPLES ACCORDING TO THE TUBE MANUFACTURER'S RECOMMENDATIONS. SIEMENS HAS BEEN WORKING WITH THE CUSTOMER TO ADDRESS THE SAMPLE HANDLING AT THE CUSTOMER SITE, AND THE CUSTOMER HAS IMPLEMENTED A NEW CENTRIFUGE AND CENTRIFUGATION PRACTICES IN OCTOBER, 2018. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TNI RESULT IS UNKNOWN. THE INSTRUMENT IS OPERATING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. RESULTS CODE WAS UPDATED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CCC SPECIALIST REVIEWED THE INSTRUMENT FILES. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE INSPECTED THE SYSTEM AND FOUND A KINKED AN DAMAGED TUBING BETWEEN THE SAMPLE PUMP SYRINGE AND SAMPLE METERING SYRINGE AND REPLACED AND POSITIONED IT. THE CSE PERFORMED PANEL PUMP TITRATION, CHECKED THE ALIGNMENTS AND CUVETTE MANUFACTURING. THE LOCI STATISTICS WERE RESET AND RUN. ALL TESTS PASSED. SERVICE METHODS TESTS WERE PERFORMED AND WERE WITHIN SPECIFICATIONS. THE CSE RAN QUALITY CONTROLS AND PATIENT SAMPLES WHICH MET PRECISION AND ACCURACY SPECIFICATIONS. SYSTEMS CHECK AND QC WERE RUN AND PASSED. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TNI RESULT IS UNKNOWN. THE INSTRUMENT IS OPERATING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN-I (TNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE PATIENT WAS HOSPITALIZED. THE ORIGINAL SAMPLE WAS REPEATED SEVERAL TIMES ON AN ALTERNATE INSTRUMENT, RESULTING LOWER. A NEW SAMPLE DRAW FROM THE PATIENT WAS TESTED ON THE SAME DIMENSION EXL INSTRUMENT AND RESULTED LOWER. THE REDRAW SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND AN ALTERNATE INSTRUMENT, RESULTING LOWER. THE RESULTS OBTAINED FROM THE NEW SAMPLE WERE ISSUED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TNI RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675671 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JJE DIMENSION EXL WITH LM DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR