BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROPONIN I (TPI) IMMULITE 2000

    MDR report key: 8708085 · Received June 18, 2019

    Report

    Report Number
    2432235-2019-00215
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    May 29, 2019
    Report Date
    July 5, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    MMI
    PMA / PMN Number
    K983972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2019-000215 ON 18-JUN-2019. ADDITIONAL INFORMATION (24-JUN-2019): SIEMENS INVESTIGATION IDENTIFIED THAT THE ORIGINAL TROPONIN KIT LOT 294 WAS WITHIN THE STATED ON-BOARD STABILITY AND NO OTHER PATIENT SAMPLES WERE RUN USING KIT LOT 294 ON THE DAY OF THE EVENT, AT THE SITE LISTED IN THE COMPLAINT. QUALITY CONTROL (QC) WAS ELEVATED AT THE TIME THE DISCORDANT RESULTS WERE RUN ON THIS PACK. NO OTHER TESTS WERE REPORTED AS AN ISSUE ON THE SYSTEM WHICH RAN THE DISCORDANT TROPONIN RESULT, THEREFORE AN INSTRUMENT ISSUE IS NOT SUSPECTED NOR IS A PRE-ANALYTICAL ISSUE BECAUSE THE SAMPLES REPRODUCED AS ELEVATED ON KIT LOT 294. SIEMENS REVIEWED THE COMPLAINT DATABASE AND DETERMINED THAT THERE WERE NO SIMILAR COMPLAINTS FOUND FOR KIT LOT 294. WHILE THE CAUSE OF THE INITIALLY REPRODUCIBLE FALSELY ELEVATED RESULTS CANNOT BE DETERMINED, SIEMENS CANNOT RULE OUT SHIPPING/HANDLING/STORAGE OF THE PACK OF KIT LOT 294. THE COMPLAINT WAS RESOLVED BY PERFORMING ROUTINE TROUBLESHOOTING. NO PRODUCT PERFORMANCE ISSUE IS CONFIRMED BECAUSE THIS HAS NOT BEEN DETERMINED TO BE A SYSTEMIC ISSUE. THE CUSTOMER IS OPERATIONAL ON KIT LOT 295. SECTION H6: RESULTS AND CONCLUSION CODES ARE UPDATED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT THEY OBTAINED DISCORDANT, FALSELY ELEVATED TROPONIN I (TPI) RESULTS ON AN IMMULITE 2000 XPI INSTRUMENT. THE CAUSE FOR THE DISCORDANT, FALSELY ELEVATED TPI RESULTS IS UNKNOWN. IT WAS DETERMINED THAT THE LEVEL 2 QUALITY CONTROL (QC) WAS ELEVATED OUTSIDE THE INSERT RANGES DURING THE TIME OF THE RUNS ON ASSAY KIT LOT # 294. SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A FALSELY ELEVATED TROPONIN I (TPI) RESULT ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, USING KIT LOT 294. THE CUSTOMER RECALIBRATED THE KIT LOT 294 AND REPEATED THE SAME SAMPLE ON THE SAME INSTRUMENT IN DUPLICATE, AND BOTH REPEAT RESULTS WERE ALSO FALSELY ELEVATED. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER CHANGED TO KIT LOT 295 AND REPEATED THE SAME SAMPLE IN DUPLICATE ON THE SAME INSTRUMENT, WITH BOTH RESULTS COMING OUT LOWER AND AS EXPECTED. THE RESULTS FROM KIT LOT 295 WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TPI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503050 TROPONIN I (TPI) IMMULITE 2000 TROPONIN I (TPI) IMMULITE 2000 MMI SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED TROPONIN I IMMULITE 2000 294

    Patients

    Seq Age Sex Outcome Treatment
    1