BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 23401822 · Received October 28, 2025

    Report

    Report Number
    3005094123-2025-00541
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 14, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. HOWEVER, NO COMMONALITIES FOR THE COMPLAINT LOT AND ISSUE WERE IDENTIFIED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 71455UD00 AND THE COMPLAINT ISSUE. IN-HOUSE ACCURACY TESTING OF A RETAINED KIT OF LOT 71455UD00 WAS COMPLETED. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. THE OVERALL PERFORMANCE OF THE ALINITY I TOTAL B-HCG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. 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. LABELING WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOTAL B-HCG REAGENT LOT 71455UD00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SIDS (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P51-30, 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 OBSERVED A DECREASED ALINITY I TOTAL -HCG RESULT FOR A 39-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (INTERPRETATION OF RESULTS <5.00 MIU/ML IS NEGATIVE, >/=25.00 MIU/ML IS POSITIVE): ON (B)(6) 2025, SAMPLE ID (B)(6), RESULT = 392 IU/L, (B)(6) 2025, SAMPLE ID (B)(6), INITIAL RESULT = <2,300 MIU/ML, (B)(6) 2025, SAMPLE ID (B)(6), RESULT = <2.3 IU/L, (B)(6) 2025, PATIENT TESTED AT ANOTHER LABORATORY DUE TO A POSSIBLE MISCARRIAGE AND RESULT = 3593 IU/L, (B)(6) 2025, SAME SAMPLE WAS ANALYZED AFTER BEING FROZEN, THAWED, AND DILUTED. RESULT = ABOUT 2000 MIU/ML. ALL SAMPLE IDS ARE FOR THE SAME PATIENT. MIU/ML = IU/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A DECREASED ALINITY I TOTAL -HCG RESULT FOR A 39-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (INTERPRETATION OF RESULTS <5.00 MIU/ML IS NEGATIVE, >/=25.00 MIU/ML IS POSITIVE): (B)(6) 2025 SAMPLE ID (B)(6) RESULT = 392 IU/L. (B)(6) 2025 SAMPLE ID (B)(6) INITIAL RESULT = <2,300 MIU/ML. (B)(6) 2025 SAMPLE ID (B)(6) RESULT = <2.3 IU/L. (B)(6) 2025 PATIENT TESTED AT ANOTHER LABORATORY DUE TO A POSSIBLE MISCARRIAGE AND RESULT = 3593 IU/L. (B)(6) 2025 SAME SAMPLE WAS ANALYZED AFTER BEING FROZEN, THAWED, AND DILUTED. RESULT = ABOUT 2000 MIU/ML. ALL SAMPLE IDS ARE FOR THE SAME PATIENT. MIU/ML = IU/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352077 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 71455UD00 00380740121501

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)