BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 24039230 · Received January 12, 2026

    Report

    Report Number
    3005094123-2026-00013
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    November 3, 2025
    Report Date
    January 19, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER, A2 - AGE AT TIME OF EVENT, A2 - AGE UNITS (PATIENT), A3A - SEX: SAMPLE ID (B)(6), 28-YEAR-OLD FEMALE, SAMPLE ID (B)(6), 28-YEAR-OLD FEMALE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P51-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21 / 31, WITH 510K/PMA/BLA NUMBER K170317. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I TOTAL B-HCG, 07P51-20, LONGFORD TO ALINITY I PROCESSING MODULE, 03R65-01, IRVING, USA. MDR NUMBER 3016438761-2026-00033-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. SECTION E UPDATED TO REFLECT UPDATED INITIAL REPORTER INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED (</=5.00 MIU/ML IS NEGATIVE, >/=25.00 MIU/ML IS POSITIVE): SAMPLE ID (B)(6), 28-YEAR-OLD FEMALE, INITIAL RESULT, ON (B)(6) 2025, WAS 93.58, REPEAT RESULTS, ON (B)(6) 2025, WERE <1.10 MIU/ML, WHICH WAS MEASURED MULTIPLE TIMES WITH THE SAME RESULT SAMPLE ID (B)(6), 28-YEAR-OLD FEMALE, INITIAL RESULT, ON (B)(6) 2025, WAS 4.32, REPEAT RESULT, ON (B)(6) 2025, WERE 42.83 AND <1.10 MIU/ML, WHICH WAS MEASURED MULTIPLE TIMES WITH THE SAME RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED (</=5.00 MIU/ML IS NEGATIVE , >/=25.00 MIU/ML IS POSITIVE): SAMPLE ID (B)(6), 28 YEAR-OLD FEMALE, INITIAL RESULT, ON (B)(6) 2025, WAS 93.58, REPEAT RESULTS, ON (B)(6) 2025, WERE <1.10 MIU/ML, WHICH WAS MEASURED MULTIPLE TIMES WITH THE SAME RESULT SAMPLE ID (B)(6), 28-YEAR-OLD FEMALE, INITIAL RESULT, ON (B)(6) 2025, WAS 4.32, REPEAT RESULT, ON (B)(6) 2025, WERE 42.83 AND <1.10 MIU/ML, WHICH WAS MEASURED MULTIPLE TIMES WITH THE SAME RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106621 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 76209UD00 00380740121501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)