BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNESIUM

    MDR report key: 18029935 · Received October 30, 2023

    Report

    Report Number
    3005094123-2023-00285
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    October 6, 2023
    Report Date
    January 4, 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
    AS
    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.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM MAGNESIUM, LIST NUMBER 08P19-34, LONGFORD TO ALINITY C PROCESSING MODULE, 03R67-01, IRVING IA/CC. MDR NUMBER 3016438761-2024-00007-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. H3 OTHER TEXT : AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM MAGNESIUM, LIST NUMBER 08P19-34, LONGFORD TO ALINITY C PROCESSING MODULE, 03R67-01, IRVING IA/CC. MDR NUMBER 3016438761-2024-00007-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SID (B)(6) INITIAL RESULT = 6.35 MMOL/L, REPEAT ON AN ARCHITECT = 0.86 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SID (B)(6) INITIAL RESULT = 6.35 MMOL/L, REPEAT ON AN ARCHITECT = 0.86 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157045 MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ABBOTT IRELAND DIAGNOSTICS DIVISION 52268UD00 00380740176532

    Patients

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