BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HCG+SS

    MDR report key: 24529229 · Received March 6, 2026

    Report

    Report Number
    1823260-2026-00792
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 3, 2026
    Report Date
    April 17, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    UDI-DI
    04015630939732
    PMA / PMN Number
    K003178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION NOTED THAT THE CUSTOMER'S TUBES WERE NOT PROPERLY SITTING IN THE RACK (NOT CENTERED), AND PARTICLES, OILY FILM, AND BUBBLES WERE OBSERVED IN THE SAMPLE. A GENERAL PRODUCT PROBLEM WAS EXCLUDED. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE.

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE QC WAS ACCEPTABLE. THE ALARM TRACE SHOWED SOME "SAMPLE SHORT" AND "CLOT DETECTION" ALARMS. THE FIELD SERVICE REPRESENTATIVE REPLACED THE MEASURING CELL AND NOTED THAT THE MAINTENANCE FOR THE MEASURING CELLS AND THE GEAR PUMP HEAD WAS OVERDUE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: THE INITIAL RESULT WAS 517 MUI/ML. SAMPLE 2: ON (B)(6) 2026, A NEW SAMPLE FROM THE SAME PATIENT WAS TESTED, AND THE RESULT WAS 0.200 MUI/ML WITH A DATA FLAG (REPORTED AS <1 MUI/ML). SAMPLE 3: DUE TO THE DISCREPANCY BETWEEN THE TWO SAMPLE RESULTS, A THIRD SAMPLE WAS TESTED, AND THE RESULT WAS <1 MUI/ML. ON (B)(6) 2025, THE INITIAL SAMPLE (SAMPLE 1) WAS REPEATED, AND THE RESULTS WERE 0.804 MIU/ML (REPORTED AS <1 MUI/ML) AND 0.200 MUI/ML WITH A DATA FLAG (REPORTED AS <1 MUI/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110725 ELECSYS HCG+SS SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ROCHE DIAGNOSTICS HCG+BETA 86890601 04015630939732

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Unknown