BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 24591446 · Received March 13, 2026

    Report

    Report Number
    3016438761-2026-00132
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    January 29, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    K170316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SIDS (B)(6) (REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THE INITIAL REPORT WAS SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3005094123-2026-00077-00 (ABBOTT IRELAND DIAGNOSTICS DIVISION, LONGFORD AS MANUFACTURING SITE) WITH SUSPECT MEDICAL DEVICE OF ALINITY C MAGNESIUM, LIST NUMBER 08P19-25. AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED ON 02MAR2026 TO ALINITY C PROCESSING MODULE (ABBOTT LABORATORIES, IRVING, TX AS MANUFACTURING SITE), WHICH IS UNDER THIS REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS FOR MULTIPLE PATIENTS WHEN PROCESSED ON THE ALINITY C PROCESSING MODULES. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. (B)(6) 2026, 37YEARS FEMALE: SID: (B)(6); INITIAL RESULT= 7.6 MG/DL, REPEAT RESULT = 2.1 MG/DL. (B)(6) (B)(6) 2026, 66 YEARS MALE: SID: (B)(6); INITIAL RESULT (B)(6) = 7.5 MG/DL, REPEAT RESULT = 1.9 MG/DL. (B)(6) (B)(6) 2026, SID (B)(6), INITIAL RESULT =8.1 MG/DL AND REPEAT RESULT =1.8 MG/DL. THE CUSTOMER USE REFERENCE RANGE: 1.6-2.6 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495436 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1