BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT MAGNESIUM

    MDR report key: 22047642 · Received May 19, 2025

    Report

    Report Number
    3005094123-2025-00242
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    May 7, 2025
    Report Date
    May 23, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JGJ
    UDI-DI
    00380740169862
    PMA / PMN Number
    K181748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. E1 - POSTAL CODE: A LEADING ZERO WAS ADDED TO THE FIELD BECAUSE THE SYSTEM REQUIRES A MINIMUM OF 5 DIGITS IN THE POSTAL CODE FIELD.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT MAGNESIUM, LIST NUMBER 03P68-34 , AND MANUFACTURING SITE: ABBOTT IRELAND DIAGNOSTICS DIVISION, LISNAMUCK, LONGFORD, IRELAND, N39E932, TO ARCHITECT C16000 PROCESSING MODULE, LIST NUMBER 03L77-01, ABBOTT LABORATORIES, 1915 HURD DRIVE, IRVING, TX, 75038. MDR NUMBER 3016438761-2025-00314 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED IMPRECISE MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 0.61-1.03 MMOL/L): INITIAL RESULT = 1.02 MMOL/L; REPEAT RESULT = 0.52 MMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED IMPRECISE MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 0.61-1.03 MMOL/L): INITIAL RESULT = 1.02 MMOL/L; REPEAT RESULT = 0.52 MMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049772 ARCHITECT MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ABBOTT IRELAND DIAGNOSTICS DIVISION 71411UD00 00380740169862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC C16K PRC MOD, 03L77-01, (B)(6)| ARC C16K PRC MOD, 03L77-01, (B)(6)