BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 20857215 · Received December 5, 2024

    Report

    Report Number
    1823260-2024-03546
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 5, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TROPONIN T REAGENT LOT NUMBER WAS 771985. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND A CUP STUCK UNDER THE REAGENT LID, WHICH CAUSED A PIPETTE TIP TO HIT THE LID AND FALL OFF. THE CUP WAS REMOVED FROM UNDER THE REAGENT LID. THE GRIPPER WAS CHECKED AND NO ALARMS OCCURRED. PRECISION STUDIES WERE CARRIED OUT. OPERATIONAL AND MECHANICAL CHECKS PASSED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TROPONIN T GEN 5 STAT ASSAY ON A COBAS E 411 ANALYZER. THE CUSTOMER ALSO MENTIONED THEY RECEIVED AN ERROR ON THE ANALYZER INDICATING THAT THE GRIPPER DID NOT PICK UP A CUP AT THE HOME POSITION. THE SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF < 6 PG/ML WITH A DATA FLAG. THE VALUE WAS QUESTIONED SINCE THE PATIENT PREVIOUSLY HAD A VALUE OF 26 PG/ML. THE SAMPLE WAS REPEATED, RESULTING IN A TROPONIN T VALUE OF 25 PG/ML. THE REPEAT VALUE WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202415 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown