BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS STAT

    MDR report key: 17591125 · Received August 21, 2023

    Report

    Report Number
    1823260-2023-02719
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 26, 2023
    Report Date
    September 19, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVIEWED THE QC DATA. THE QC WAS WITHIN THE ASSIGNED RANGES ON THE DAY OF SAMPLE MEASUREMENT. THE INVESTIGATION REVIEWED THE CUSTOMER'S ANSWERS REGARDING PATIENT SAMPLING INQUIRIES; NO ISSUES WERE NOTED. THE FIELD SERVICE ENGINEER (FSE) VERIFIED THE ALIGNMENTS OF THE ANALYZER. THE FSE PERFORMED A LIQUID-LEVEL CHECK (LLC) FOR THE SAMPLE PROBE WHICH GAVE A HIGH RESULT. HE THEN PERFORMED MORE ADJUSTMENTS. HE PERFORMED SYSTEM VOLUME AND PRECISION CHECKS WITH SUCCESSFUL RESULTS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE. THE INVESTIGATION EXCLUDED A GENERAL REAGENT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS (B)(6). THE INVESTIGATION REVIEWED THE QC DATA; THE QC WAS WITHIN THE ASSIGNED RANGES ON THE DAY OF SAMPLE MEASUREMENT. THE FIELD SERVICE ENGINEER INVESTIGATED THE ISSUE AND I NOTED THAT THE CUSTOMER USES SAMPLE CUPS NOT VALIDATED FOR THIS MODEL OF QC EQUIPMENT. PRODUCT LABELING STATES "SAMPLE CUPS (1),(2) ROCHE-CERTIFIED 2 ML SAMPLE CUPS DO NOT USE MICRO CUPS." THE FSE VERIFIED THAT THE ALIGNMENTS WERE WITHIN SPECIFICATIONS. HE CHECKED THE LIQUID LEVEL DETECTION (LLD) OF THE SAMPLE PROBE. HE PERFORMED A SYSTEM VOLUME CHECK AND PRECISION TESTS WITH SUCCESSFUL RESULTS. THE INVESTIGATION EXCLUDED A GENERAL REAGENT PROBLEM. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TROPONIN T HS STAT RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 411. THE INITIAL RESULT WAS CONSIDERED INCORRECT AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT AT 11:37 AM WAS 376.5 PG/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT AT 11:59 AM WAS 4.57 PG/ML. THE SECOND REPEAT RESULT AT 12:25 PM WAS 4.91 PG/ML. THE THIRD REPEAT RESULT AT 1:14 PM WAS 5.04 PG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091420 ELECSYS TROPONIN T HS STAT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 68812401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown