BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 18518519 · Received January 16, 2024

    Report

    Report Number
    1823260-2024-00151
    Event Type
    Malfunction
    Date Received
    January 16, 2024
    Date of Event
    December 15, 2023
    Report Date
    February 2, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE SAMPLE FOAM IMAGES (SFD). BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A GENERAL REAGENT ISSUE WAS EXCLUDED AS QC WAS WITHIN RANGE PRIOR TO THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE E801 MODULE SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TROPONIN T HS (TROPONIN T HS) ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS 89 NG/L. THE REPEAT RESULT WAS 18 NG/L. THE SAMPLE WAS REPEATED ON A DIFFERENT COBAS MODULE WITH A RESULT OF 17 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854264 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 688155

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown