BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CHAGAS

    MDR report key: 19951506 · Received August 9, 2024

    Report

    Report Number
    1823260-2024-02321
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    June 18, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    QHM
    PMA / PMN Number
    125799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE PATIENT SAMPLES WERE REQUESTED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE METHOD USED AT THE EXTERNAL LABORATORY FOR PATIENT 1 WAS THE ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) FROM WIENER LABORATORIES. THE SAMPLE FROM PATIENT 2 WAS TESTED IN A DIFFERENT LABORATORY AND THE CHAGAS RESULT WAS POSITIVE. THIS CORRESPONDS TO THE ELECSYS RESULTS FROM THE E801 ANALYZER. CALIBRATION AND QC DATA FROM ALL DATES OF TESTING WERE ACCEPTABLE. THE SAMPLES FOR PATIENTS 1 AND 2 WERE NO LONGER AVAILABLE. THE SAMPLE FROM PATIENT 3 WAS RECEIVED FOR INVESTIGATION. THE SAMPLE WAS TESTED AT THE INVESTIGATION SITE AND THE ELECSYS CHAGAS RESULT WAS 1.63 COI (POSITIVE). AN IN-HOUSE NEUTRALIZATION ASSAY WAS USED AND THE SAMPLE WAS NEUTRALIZABLE. BASED ON THE RESULTS GENERATED DURING THE INVESTIGATION THE ELECSYS CHAGAS RESULTS ARE CONSIDERED TO BE CORRECTLY POSITIVE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED FALSE POSITIVE RESULTS FOR 3 PATIENT SAMPLES TESTED FOR ELECSYS CHAGAS (CHAGAS) ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2024 PATIENT 1 INITIAL RESULT WAS 3.87 COI (POSITIVE). THE REPEAT RESULT WAS 3.94 COI (POSITIVE). ON (B)(6) 2024 THE RESULT WAS 3.87 COI (POSITIVE). THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY WHERE THE RESULT FROM AN UNKNOWN METHOD WAS "NEGATIVE." THE SPECIFIC RESULT WAS NOT PROVIDED. ON (B)(6) 2024 PATIENT 2 INITIAL RESULT WAS 129 COI (POSITIVE). THE REPEAT RESULT WAS 128 COI (POSITIVE). ON (B)(6) 2024 PATIENT 3 INITIAL RESULT WAS 1.46 COI (POSITIVE). THE REPEAT RESULT WAS 1.46 COI (POSITIVE). ON (B)(6) 2024 THE RESULT WAS 1.49 COI (POSITIVE). ON (B)(6) 2024 THE SAMPLE WAS TESTED WITH A NEW REAGENT LOT (783558, EXPIRATION 31- DEC-2025) AND THE RESULT WAS 1.25 (COI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257958 ELECSYS CHAGAS ELECSYS CHAGAS QHM ROCHE DIAGNOSTICS 70254301, 783558

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown