BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS STAT

    MDR report key: 21197280 · Received January 21, 2025

    Report

    Report Number
    1823260-2025-00191
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    December 28, 2024
    Report Date
    April 3, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD D4 EXPIRATION DATE WAS UPDATED. THE CALIBRATION RESULTS WERE WITHIN THE SPECIFIED RANGES. THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THE ALARM TRACE HAD MULTIPLE SAMPLE SHORT, SAMPLE CLOT, AND SAMPLE FOAM ALARMS. THE ANALYSIS OF THE SAMPLE FOAM DETECTION (SFD) CAMERA IMAGE OF THE INITIAL PATIENT SAMPLE SHOWED WHITE PARTICULATE MATTER AND BUBBLES/FOAM IN THE REPEAT PATIENT SAMPLE. A GENERAL REAGENT PROBLEM WAS NOT PRESENT BECAUSE THE QCS BEFORE THE EVENT WERE WITHIN THE SPECIFIED RANGES; ISOLATED NON-REPRODUCIBLE RESULTS ALSO DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A SAMPLE QUALITY ISSUE (ABNORMALITIES BASED ON IMAGES FROM THE SFD CAMERA). THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S- COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TNT HS (TNTHS) STAT RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2024 : THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 16.9 NG/L (>14 NG/L) WITH A DATA FLAG. THE FIRST REPEAT RESULT OF THE INITIAL PATIENT SAMPLE WAS 3.90 NG/L (4 NG/L). THE INITIAL RESULT OF THE REPEAT PATIENT SAMPLE WAS 4.09 NG/L. THE REPEAT RESULT OF THE REPEAT PATIENT SAMPLE WAS 3.44 NG/L. ON (B)(6) 2024 : THE SECOND REPEAT RESULT OF THE INITIAL PATIENT SAMPLE WAS 3 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722292 ELECSYS TROPONIN T HS STAT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 770528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown