BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 24605488 · Received March 16, 2026

    Report

    Report Number
    3005094123-2026-00126
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 16, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP 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 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21/-31 WITH 510K/PMA/BLA NUMBER K170317.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR A 44-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2026, SID (B)(6): HCG RESULT = 44.08 MIU/ML (POSITIVE RESULT AND WAS RELEASED). ON (B)(6)2026, THE PATIENT QUESTIONED THE RESULT, AND A NEW SAMPLE WAS DRAWN AND TESTED WITH SID (B)(6) GENERATING A HCG RESULT OF < 2.3 MIU/ML (NEGATIVE). ON (B)(6) 2026 THE CUSTOMER CALIBRATED THE TOTAL B-HCG REAGENT, WHICH SHOWED SLIGHTLY LOW RLU VALUES ON POINTS A AND B COMPARED TO THE PREVIOUS CALIBRATION. ON (B)(6) 2026, CONTROL LEVEL 1 GENERATED A HIGH VALUE OF 4.77 MIU/ML (EXPECTED MEAN OF 3.98 MIU/ML AND EXPECTED RANGE 2.78-5.77 MIU/ML), WHICH WAS STILL WITHIN RANGE. ON (B)(6) 2026, THE ALINITY I TOTAL B-HCG REAGENT WAS RECALIBRATED USING A NEW CALIBRATOR; POINTS A AND B SHOWED AN RLU READING MORE IN LINE WITH HISTORY. THE CONTROLS RUN AFTER THAT RECALIBRATION WERE ALIGNED WITH THE EXPECTED MEAN. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671067 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 81525UD00 00380740121501

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)