BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HCG+SS

    MDR report key: 23349702 · Received October 21, 2025

    Report

    Report Number
    1823260-2025-04274
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 19, 2025
    Report Date
    December 9, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    UDI-DI
    04015630939732
    PMA / PMN Number
    K003178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROVIDED SAMPLE FOAM DETECTION IMAGES SHOWED NO ISSUES WITH THE SAMPLE QUALITY AND THE GRIPPERS. THERE WAS NO HINT OF A REAGENT ISSUE. AFTER THE FIELD SERVICE ENGINEER REPLACED THE MEASURING CELLS, THE ISSUE WAS RESOLVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). QC WAS WITHIN THE ASSIGNED RANGES ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS HCG+SS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: SAMPLE 1: INITIAL RESULT: 60.3 IU/L. ON (B)(6) 2025: A NEW SAMPLE (SAMPLE 2) WAS DRAWN FROM THE PATIENT AND TESTED, RESULTING IN A VALUE OF <0.200 IU/L (ACCOMPANIED BY A DATA FLAG). SAMPLE 1: REPEAT RESULT: <0.200 IU/L (ACCOMPANIED BY A DATA FLAG). PATIENT 2: ON (B)(6) 2025: SAMPLE 1: INITIAL RESULT: 425 IU/L. REPEAT RESULT: 0.<200 IU/L (ACCOMPANIED BY A DATA FLAG). ON (B)(6) 2025: A NEW SAMPLE (SAMPLE 2) WAS DRAWN FROM THE PATIENT AND TESTED, RESULTING IN A VALUE OF <0.200 IU/L (ACCOMPANIED BY A DATA FLAG). THE RESULTS OF <0.200 IU/L WERE DEEMED TO BE CORRECT, AS PATIENT 1 AND PATIENT 2 WERE CONFIRMED NOT TO BE PREGNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841584 ELECSYS HCG+SS SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ROCHE DIAGNOSTICS HCG+BETA 868906 04015630939732

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female