BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 23888285 · Received December 24, 2025

    Report

    Report Number
    3005094123-2025-00664
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    November 30, 2025
    Report Date
    May 4, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P51 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21 / 31, WITH 510K NUMBER K170317. COMPLETE INFORMATION FROM SECTION A1 PATIENT IDENTIFIER: SID (B)(6).

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I TOTAL B-HCG REAGENT LOT 73562UD00 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY DEPRESSED RESULTS. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ALINITY I TOTAL SS-HCG ASSAY USING WORLDWIDE DATA. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR THE LOT IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. LABELLING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I TOTAL B-HCG REAGENT LOT 73562UD00.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TOTAL B-HCG RESULTS FOR ONE FEMALE PATIENT. THE INITIAL ALINITY I TOTAL B-HCG RESULT FROM 30NOV2025 FOR SID (B)(6) WAS <2.30 MIU/ML, REPEATED ON 04DEC2025 AND THE RESULT FROM THE SAME SPECIMEN WAS 48.59 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TOTAL B-HCG RESULTS FOR ONE FEMALE PATIENT. THE INITIAL ALINITY I TOTAL B-HCG RESULT FROM (B)(6) 2025 FOR SID (B)(6) WAS <2.30 MIU/ML, REPEATED ON (B)(6) 2025 AND THE RESULT FROM THE SAME SPECIMEN WAS 48.59 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80561 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 73562UD00 00380740121501

    Patients

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