BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C MAGNESIUM

    MDR report key: 24337539 · Received February 13, 2026

    Report

    Report Number
    3005094123-2026-00071
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 25, 2026
    Report Date
    February 20, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JGJ
    UDI-DI
    00380740176525
    PMA / PMN Number
    K181748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY C MAGNESIUM, LIST NUMBER 08P19-25, ABBOTT IRELAND DIAGNOSTICS DIVISION TO ALINITY C PROCESSING MODULE, LIST NUMBER 03R67-01, ABBOTT LABORATORIES. MDR NUMBER 3016438761-2026-00102 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM ON THE ALINITY C PROCESSING MODULE FOR A 46-YEAR-OLD FEMALE. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER WITH LOWER RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED (REFERENCE RANGE 1.9 - 2.5 MG/DL): SID: (B)(6), INITIAL MAGNESIUM RESULT= 7.66 MG/DL; REPEAT RESULT ON THE OTHER ANALYZER= 1.51 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM ON THE ALINITY C PROCESSING MODULE FOR A 46-YEAR-OLD FEMALE. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER WITH LOWER RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED (REFERENCE RANGE 1.9 - 2.5 MG/DL): SID (B)(6), INITIAL MAGNESIUM RESULT= 7.66 MG/DL; REPEAT RESULT ON THE OTHER ANALYZER= 1.51 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391530 ALINITY C MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ABBOTT IRELAND DIAGNOSTICS DIVISION UNKNOWN 00380740176525

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female ALNTY C PROCESSING MODU, 03R67-01, (B)(6).| ALNTY C PROCESSING MODU, 03R67-01, (B)(6).