BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNESIUM

    MDR report key: 18302043 · Received December 11, 2023

    Report

    Report Number
    3005094123-2023-00364
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    December 1, 2023
    Report Date
    February 22, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY C MAGNESIUM, LIST 08P19-34, ABBOTT IRELAND DIAGNOSTICS DIVISION, LONGFORD, IRELAND TO THE ALINITY C PROCESSING MODULE, LIST 03R67-01, ABBOTT LABORATORIES, IRVING, TEXAS, USA. MDR NUMBER 3016438761-2024-00113-00 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. COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER IS (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C MAGNESIUM RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED WHICH WAS NOT REPORTED OUT OF THE LAB: SID (B)(6)PROCESSED ON (B)(6)2023 INITIAL MAGNESIUM RESULT = 3.44 MMOL/L REPEAT 0.53 MMOL/L REFERENCE RANGE = 0.66-1.07 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C MAGNESIUM RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED WHICH WAS NOT REPORTED OUT OF THE LAB: SID (B)(6) PROCESSED ON (B)(6) 2023 INITIAL MAGNESIUM RESULT = 3.44 MMOL/L REPEAT 0.53 MMOL/L REFERENCE RANGE = 0.66-1.07 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180550 MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ABBOTT IRELAND DIAGNOSTICS DIVISION 52268UD00 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)