BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 24111225 · Received January 19, 2026

    Report

    Report Number
    3016438761-2026-00033
    Event Type
    Malfunction
    Date Received
    January 19, 2026
    Date of Event
    November 3, 2025
    Report Date
    January 19, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3005094123-2026-00013-00 UNDER A DIFFERENT SUSPECT DEVICE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE ID (B)(6) AND SAMPLE ID (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS ON THE ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR PERFORMED MULTIPLE TROUBLESHOOTING PROCEDURES; HOWEVER, A SINGLE DEFINITIVE LIKELY CAUSE FOR THE DISCREPANT RESULT WAS NOT FOUND. THE ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6), WAS CONSIDERED THE LIKELY CAUSE OF THE ISSUE. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED (</=5.00 MIU/ML IS NEGATIVE, >/=25.00 MIU/ML IS POSITIVE): SAMPLE ID (B)(6), 28-YEAR-OLD FEMALE, INITIAL RESULT, ON (B)(6) 2025, WAS 93.58, REPEAT RESULTS, ON (B)(6) 2025, WERE <1.10 MIU/ML, WHICH WAS MEASURED MULTIPLE TIMES WITH THE SAME RESULT SAMPLE ID (B)(6), 28-YEAR-OLD FEMALE, INITIAL RESULT, ON (B)(6) 2025, WAS 4.32, REPEAT RESULT, ON (B)(6) 2025, WERE 42.83 AND <1.10 MIU/ML, WHICH WAS MEASURED MULTIPLE TIMES WITH THE SAME RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173256 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female ALNTY I TOTAL BHCG 200T, 07P51-20, (B)(6)