BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 25332470 · Received May 29, 2026

    Report

    Report Number
    3005094123-2026-00256
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 16, 2026
    Report Date
    May 29, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P51-20 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21/-31, AND A 510K/PMA/BLA NUMBER OF K170317.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I TOTAL -HCG RESULT GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (INTERPRETATION OF RESULTS </= 5.00 MIU/ML IS NEGATIVE, > 5.00 MIU/ML TO < 25.00 MIU/ML = GRAYZONE, >/= 25.00 MIU/ML IS POSITIVE). (B)(6) 2026 SAMPLE ID (B)(6), PATIENT HAD IVF PROCEDURE DONE AND SAMPLE WAS DRAWN AFTER. INITIAL RESULT = 74.40 MIU/ML, 18MAY2026 RESULTS = <2.30 MIU/ML, <2.30 MIU/ML. (B)(6) 2026 SAME PATIENT, NEW SAMPLE OBTAINED. SAMPLE ID (B)(6) INITIAL RESULT = <2.30 MIU/ML, REPEAT RESULTS = <2.30 MIU/ML, <2.30 MIU/ML, <2.30 MIU/ML, 6.58 MIU/ML, <2.30 MIU/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144064 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 83405UD00 00380740121501

    Patients

    Seq Age Sex Outcome Treatment
    1