BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 20951422 · Received December 17, 2024

    Report

    Report Number
    1823260-2024-03705
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 27, 2024
    Report Date
    February 4, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. THE CUSTOMER USED A CENTRIFUGATION TIME OF 8 MINUTES AT 3040 G. FOAM WAS OBSERVED ON THE SURFACE OF THE SAMPLE. SAMPLE FOAM DETECTION (SFD) IMAGES WERE REVIEWED. THERE WAS NO DUST ON THE ACTIVE WHEELS AND THE ACTIVE GRIPPER WHEELS WERE WELL ADJUSTED. DURING INITIAL TESTING, FOAM WAS PRESENT ON THE SAMPLE. THE INITIAL PIPETTING DIDN'T TRIGGER AN SFD ALARM, HOWEVER, A FOAM DETECTION ALARM WAS TRIGGERED FOR THE REPEAT TEST. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING. E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6).

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS RESULTS FOR ONE PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 70.3 PG/ML. THE REPEAT RESULT WAS 5.60 PG/ML. THE INITIAL RESULT WAS QUESTIONED AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND WAS NOT REPORTED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266172 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 77052801

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male