BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 18608123 · Received January 30, 2024

    Report

    Report Number
    1823260-2024-00263
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    May 29, 2023
    Report Date
    June 18, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO SAMPLES FROM THE PATIENT WERE SUBMITTED FOR INVESTIGATION. BOTH SAMPLES WERE HEMOLYTIC. BOTH SAMPLES WERE TESTED FOR TNI STAT, TNT HS, MYOGLOBIN, AND CK-MB ON AN E602 MODULE. SAMPLE 1: CK-MB: 3.18 NG/ML. MYOGLOBIN: 57.32 NG/ML. TNI STAT: <TEST. TNT HS: 98.09 PG/ML. SAMPLE 2: CK-MB: 3.11 NG/ML, MYOGLOBIN: 52.45 NG/ML, TNI STAT: 0.126 NG/ML, TNT HS: 86.95 PG/ML. THE CUSTOMER'S ELEVATED TNT HS RESULTS WERE REPRODUCED DURING THE INVESTIGATION. ALL OTHER ASSAY RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE SAMPLES UNDERWENT INTERFERENCE TESTING BY SIZE EXCLUSION CHROMATOGRAPHY (SEC). NO INTERFERING FACTORS WERE IDENTIFIED. THE PATIENT HAS CHRONIC KIDNEY DISEASE (STAGE 3). PATIENTS WITH THIS CONDITION MAY HAVE ELEVATED TROPONIN LEVELS DUE TO CARDIAC INJURY ASSOCIATED WITH STRUCTURAL HEART DISEASE AND A REDUCED CLEARANCE RATE OF TROPONIN VIA THE KIDNEYS. THIS PATIENT MAY HAVE CHRONICALLY ELEVATED TROPONIN LEVELS WITHOUT THE PRESENCE OF ACUTE MYOCARDIAL INFARCTION (AMI). THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE E602 MODULE SERIAL NUMBER WAS (B)(6) .

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TROPONIN T HS (TROPONIN T HS) ON A COBAS 8000 E 602 MODULE. THE INITIAL RESULT FROM THE E602 MODULE WAS 109 NG/L. THE SAMPLE WAS REPEATED ON 2 UNSPECIFIED POINT-OF-CARE INSTRUMENTS WITH RESULTS OF 4.6 NG/L AND 10 NG/L. A 2ND SAMPLE WAS OBTAINED AND THE RESULT FROM THE E602 MODULE WAS 107 NG/L. THE 2ND SAMPLE WAS REPEATED ON 2 UNSPECIFIED POINT-OF-CARE INSTRUMENTS WITH RESULTS OF 5.2 NG/L AND 10 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2550927 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male ASPIRIN| ATORVASTATIN| BISOPROLOL| DOCUSATE| FUROSEMIDE| LEVOTHYROXINE| MACROGOL| RAMIPRIL| SENNA