BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C MAGNESIUM

    MDR report key: 24349575 · Received February 16, 2026

    Report

    Report Number
    3005094123-2026-00077
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    January 29, 2026
    Report Date
    April 28, 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
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL 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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P19, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K181748.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP SUBMISSION BEING SEND TO CROSS REFERENCE MDR: 3005094123-2026-00077-01 FOR LIKELY CAUSE CHANGED ON 02MAR2026 FROM ALINITY C MAGNESIUM REAGENT, LIST: 08P19-25 TO ALINITY C PROCESSING MODULE, LIST NUMBER: 03R67-01. ALL FURTHER INFORMATION WILL BE SUBMITTED UNDER MDR: 3016438761-2026-00132-00.

    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. ON (B)(6) 2026, 37 YEARS FEMALE: SID: (B)(6) ; INITIAL RESULT= 7.6 MG/DL, REPEAT RESULT = 2.1 MG/DL. (B)(6). ON (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). ON (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.

    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. ON (B)(6) 2026, 37 YEARS FEMALE: SID: (B)(6); INITIAL RESULT= 7.6 MG/DL, REPEAT RESULT = 2.1 MG/DL. (B)(6). ON (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). ON (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
    412710 ALINITY C MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ABBOTT IRELAND DIAGNOSTICS DIVISION 77635UD00 00380740176525

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY C MAG (720T), 08P19-25, 77635UD00.| ALNTY C MAG (720T), 08P19-25, 77635UD00.