BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C MAGNESIUM

    MDR report key: 23567619 · Received November 17, 2025

    Report

    Report Number
    3005094123-2025-00575
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JGJ
    UDI-DI
    00380740176532
    PMA / PMN Number
    K181748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM THE ALINITY C MAGNESIUM, 08P19-34, ABBOTT IRELAND DIAGNOSTICS DIVISION TO ALINITY C PROCESSING MODULE, 03R67-01, ABBOTT LABORATORIES. MDR NUMBER 3016438761-2025-00739 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C MAGNESIUM RESULT FOR AN 80 YEAR OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 1.6 TO 2.3 MG/DL): 11NOV2025, SID (B)(6): INITIAL RESULT = 8.3 MG/DL, REPEAT ON ANOTHER ALINITY = 2.0 MG/DL THE DISCREPANT RESULT WAS NOT REPORTED OUT OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C MAGNESIUM RESULT FOR AN 80-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 1.6 TO 2.3 MG/DL): ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 8.3 MG/DL, REPEAT ON ANOTHER ALINITY = 2.0 MG/DL THE DISCREPANT RESULT WAS NOT REPORTED OUT OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228201 ALINITY C MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ABBOTT IRELAND DIAGNOSTICS DIVISION 74272UD01 00380740176532

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male ALNTY C PROCESSING MODU, 03R67-01, (B)(6).| ALNTY C PROCESSING MODU, 03R67-01, (B)(6).