BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 23413650 · Received October 29, 2025

    Report

    Report Number
    3005094123-2025-00544
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    September 6, 2025
    Report Date
    January 21, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. CONTINUED INFORMATION FOR SECTION A1 PATIENT IDENTIFIER AND AGE: PATIENT 1 19-YEAR-OLD: SID: (B)(6). PATIENT 2 40-YEAR-OLD: SID: (B)(6). PATIENT 3 18-YEAR-OLD: SID: (B)(6).

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I TOTAL B-HCG REAGENT, LOT 73562UD00. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF ALINITY I TOTAL B-HCG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. REVIEW SHOWS THE MEDIAN PATIENT RESULT FOR THE LOT IS WITHIN ESTABLISHED LIMITS AND COMPARABLE TO OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE. BASED ON THE INVESTIGATION, THERE IS NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOTAL B-HCG REAGENT, LOT 73562UD00. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P51-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P51-21, 510K K170317.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT GENERATED ON TWO ALINITY I PROCESSING MODULES FOR THREE FEMALE PATIENTS WITH PLASMA SAMPLES COMPARED TO THE SERUM SAMPLES. THE FOLLOWING EXAMPLES WERE PROVIDED: PATIENT 1 (19-YEAR-OLD): PLASMA SAMPLE SID: (B)(6) INITIAL RESULT ON (B)(6) = 257 MIU/ML, SERUM SAMPLE SID: (B)(6) RESULT ON (B)(6) = <2 MIU/ML, SERUM SAMPLE SID: (B)(6) RESULT ON (B)(6) = <2 MIU/ML PATIENT 2 (40-YEAR-OLD): PLASMA SAMPLE SID: (B)(6) RESULT ON (B)(6) = 95.67 MIU/ML, SERUM SAMPLE SID: (B)(6) RESULT ON (B)(6) = <2 MIU/ML PATIENT 3 (18-YEAR-OLD): PLASMA SAMPLE SID: (B)(6) RESULT ON (B)(6) = 27.58 MIU/ML, REPEAT PLASMA RESULT ON (B)(6) = 29.04 MIU/ML, SERUM SAMPLE SID: (B)(6) RESULT ON (B)(6) = <2 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT GENERATED ON TWO ALINITY I PROCESSING MODULES FOR THREE FEMALE PATIENTS WITH PLASMA SAMPLES COMPARED TO THE SERUM SAMPLES. THE FOLLOWING EXAMPLES WERE PROVIDED: PATIENT 1 (19-YEAR-OLD): PLASMA SAMPLE SID (B)(6), INITIAL RESULT ON (B)(6) = 257 MIU/ML, SERUM SAMPLE SID (B)(6) RESULT ON (B)(6) = <2 MIU/ML, SERUM SAMPLE SID (B)(6) RESULT ON (B)(6) = <2 MIU/ML. PATIENT 2 (40-YEAR-OLD): PLASMA SAMPLE SID (B)(6), RESULT ON (B)(6) = 95.67 MIU/ML, SERUM SAMPLE SID (B)(6) RESULT ON (B)(6) = <2 MIU/ML. PATIENT 3 (18-YEAR-OLD): PLASMA SAMPLE SID (B)(6) RESULT ON (B)(6) = 27.58 MIU/ML, REPEAT PLASMA RESULT ON (B)(6) = 29.04 MIU/ML, SERUM SAMPLE SID 129182 RESULT ON (B)(6) = <2 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219245 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).