BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNESIUM

    MDR report key: 20107748 · Received August 30, 2024

    Report

    Report Number
    3005094123-2024-00455
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 10, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JGJ
    UDI-DI
    00380740176532
    PMA / PMN Number
    K181748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. SECTION E1 - PHONE NUMBER COMPLETE ENTRY = (B)(6). 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 MAGNESIUM, LIST NUMBER 08P19-34, A.I.D.D LONGFORD, LISNAMUCK, CO. LONGFORD, LONGFORD, IRELAND, N39E932 TO ALINITY C PROCESSING MODULE, LIST NUMBER 03R67-01, ABBOTT LABORATORIES, 1915 HURD DRIVE, IRVING, TX, 75038. MDR NUMBER 3016438761-2024-00534-00 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 ALINITY C MAGNESIUM (MG) RESULTS GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE UPPER LIMIT 1.07 MMOL/L): SAMPLE ID (B)(6) INITIAL RESULT = 2.89 MMOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT AC1699 = 0.73 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C MAGNESIUM (MG) RESULTS GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE UPPER LIMIT 1.07 MMOL/L): SAMPLE ID (B)(6) INITIAL RESULT = 2.89 MMOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT AC1699 = 0.73 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912391 MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ABBOTT IRELAND DIAGNOSTICS DIVISION 63239UD00 00380740176532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY C PROCESSING MODU, 03R67-01, (B)(6)| ALNTY C PROCESSING MODU, 03R67-01, (B)(6)