BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HCG+BETA

    MDR report key: 21275601 · Received January 30, 2025

    Report

    Report Number
    1823260-2025-00290
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 6, 2025
    Report Date
    March 5, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K003178
    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 ANALYZER'S SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC WERE ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE SYSTEM'S ALARM TRACE SHOWED MULTIPLE "ABNORMAL SAMPLE PROBE MOVEMENT" ALARMS, INDICATING ISSUES WITH THE SAMPLE LIQUID LEVEL DETECTION (SAMPLE QUALITY/SAMPLE ASPIRATION). THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH A PRE-ANALYTICAL HANDLING ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+BETA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 601 MODULE. THE INITIAL RESULT WAS 10000 MUI/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:100 DILUTION AND THE RESULT WAS 65.85 MUI/ML. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 31000 MUI/ML. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AS THE INITIAL RESULT AND THE RESULT WAS 10000 MUI/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:100 DILUTION AND THE RESULT WAS 29441 MUI/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507297 ELECSYS HCG+BETA SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ROCHE DIAGNOSTICS HCG+BETA 774930

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female