BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT MAGNESIUM

    MDR report key: 22828004 · Received August 18, 2025

    Report

    Report Number
    3005094123-2025-00399
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    August 3, 2025
    Report Date
    September 3, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JGJ
    UDI-DI
    00380740169855
    PMA / PMN Number
    K181748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). 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.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT MAGNESIUM, LIST NUMBER 03P68-24, ABBOTT IRELAND DIAGNOSTICS DIVISION TO ARCHITECT C4000 PROCESSING MODULE, LIST NUMBER 02P24-01, ABBOTT LABORATORIES. MDR NUMBER 3016438761-2025-00505 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 ARCHITECT C4000 PROCESSING MODULE FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 1.5 ¿ 2.2 MG/DL): (B)(6) 2025, SID (B)(6) (NEWBORN), INITIAL MAGNESIUM RESULT= 5.95 MG/DL; (B)(6) 2025, REPEAT RESULT= 2.10 MG/DL (B)(6) 2025, SID (B)(6), INITIAL MAGNESIUM RESULT= 8.54 MG/DL; REPEAT RESULT= 1.70 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 1.5 ¿ 2.2 MG/DL): (B)(6) 2025, SID (B)(6) (NEWBORN), INITIAL MAGNESIUM RESULT= 5.95 MG/DL; 04AUG2025, REPEAT RESULT= 2.10 MG/DL. (B)(6) 2025, SID (B)(6), INITIAL MAGNESIUM RESULT= 8.54 MG/DL; REPEAT RESULT= 1.70 MG/DL . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542768 ARCHITECT MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ABBOTT IRELAND DIAGNOSTICS DIVISION 71414UD00 00380740169855

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC C4 PROC MOD, 02P24-01, (B)(6).| ARC C4 PROC MOD, 02P24-01, (B)(6).