BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 25112123 · Received May 7, 2026

    Report

    Report Number
    3016438761-2026-00260
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I HAVAB IGG II RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6) (19-YEAR-OLD MALE): INITIAL RESULT ON (B)(6) = POSITIVE, REPEAT ON ANOTHER ALINITY = NEGATIVE. (B)(6) 2026, SID (B)(6) (33-YEAR-OLD MALE): INITIAL RESULT ON (B)(6) = POSITIVE, REPEAT = NEGATIVE, REPEAT ON ANOTHER ALINITY = NEGATIVE. ADDITIONALLY, THE CUSTOMER NOTED A SHIFT UP IN QUALITY CONTROLS. A PRECISION STUDY WAS COMPLETED WITH SID (B)(6) FOR TROUBLESHOOTING PURPOSES: (B)(6) = 0.3, (B)(6) = 0.75, (B)(6) = 0.43, (B)(6) = 1.32, (B)(6) = 0.53, (B)(6) = 1.09, (B)(6) = 0.28, (B)(6) = 1.07, (B)(6) = 0.41, (B)(6) = 0.4. A PATIENT COMPARISON STUDY WAS COMPLETED FOR TROUBLESHOOTING PURPOSES: SAMPLE 1: (B)(6) = 10.8, (B)(6) = 9.61, SAMPLE 2: (B)(6) = 0.14, (B)(6) = 0.12, SAMPLE 3: (B)(6) = 7.25, (B)(6) = 7.48, SAMPLE 4: (B)(6) = 9.08, (B)(6) = 8.53, SAMPLE 5: (B)(6) = 8.07, (B)(6) = 8.18, SAMPLE 6: (B)(6) = 11.03, (B)(6) = 10.20, SAMPLE 7: (B)(6) = 1.26, (B)(6) = 0.73, SAMPLE 8: (B)(6) = 0.34, (B)(6) = 0.34, SAMPLE 9: (B)(6) = 0.09, (B)(6) = 0.10, SAMPLE 10: (B)(6) = 0.21, (B)(6) = 0.27. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213312 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1