BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNESIUM

    MDR report key: 11435105 · Received March 8, 2021

    Report

    Report Number
    3016438761-2021-00084
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Date of Event
    February 12, 2021
    Report Date
    June 24, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JGJ
    PMA / PMN Number
    K181748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM MAGNESIUM, LIST NUMBER 03P68-31 IN SECTION D OF THIS REPORT TO ARCHITECT C4000, LIST NUMBER 02P24-40, WITH THE MANUFACTURING SITE REMAINING THE SAME. MDR NUMBER 3016438761-2021-00103-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. COMPLETE INFORMATION FOR PATIENT IDENTIFIER = SID (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM (MG) RESULTS OCCURRING INTERMITTENTLY ON ONE PATIENT SAMPLE ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE ON (B)(6) 2021 SID (B)(6) INITIAL = 2.20MG/DL / RETEST = >8.70MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333982 MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C4000 INTGR, 02P24-40, C402044| ARC C4000 INTGR, 02P24-40, C402044| ARC C4000 INTGR, 02P24-40, C402044