BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 23716727 · Received December 4, 2025

    Report

    Report Number
    3005094123-2025-00615
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I TOTAL B-HCG REAGENT, LIST # 07P51-30, LOT # 76394UD00, ABBOTT IRELAND DIAGNOSTICS DIVISION, LISNAMUCK, LONGFORD, IRELAND, N39E932 TO ALINITY I PROCESSING MODULE, LIST NUMBER 03R65-01, ABBOTT LABORATORIES, 1915 HURD DRIVE, IRVING, TX, 75038 ON (B)(6) 2025. MDR NUMBER 3016438761-2025-00731-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: COMPLETE SAMPLE ID: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE ALINITY I TOTAL -HCG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 36-YEAR-OLD FEMALE (NOT PREGNANT) PATIENT. RESULTS WERE REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. (B)(6) 2025, SID (B)(6); INITIAL RESULTS= 41.120 IU/L (POSITIVE), REPEAT RESULTS ON (B)(6) 2025 = 2.3 IU/L (NEGATIVE). (REFERENCE RANGE = 5.00 IU/L IS NEGATIVE, = 25.00 IU/L IS POSITIVE): THERE WAS NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE ALINITY I TOTAL -HCG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 36-YEAR-OLD FEMALE (NOT PREGNANT) PATIENT. RESULTS WERE REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. ON (B)(6) 2025, SID: (B)(6); INITIAL RESULTS= 41.120 IU/L (POSITIVE), REPEAT RESULTS ON (B)(6) 2025 = 2.3 IU/L (NEGATIVE). (REFERENCE RANGE = 5.00 IU/L IS NEGATIVE, = 25.00 IU/L IS POSITIVE): THERE WAS NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891327 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 76394UD00 00380740121518

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6).