BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNESIUM

    MDR report key: 11050608 · Received December 21, 2020

    Report

    Report Number
    3002809144-2020-01203
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    December 8, 2020
    Report Date
    January 18, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    JGJ
    UDI-DI
    00380740161620
    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

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM MAGNESIUM, LIST NUMBER 03P68-22, MANUFACTURING SITE WIESBADEN, GERMANY, WHICH WAS SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3002809144-2020-01203-00 TO ARCHITECT C4000 ANALYZER, LIST NUMBER 02P24-40, MANUFACTURING SITE IRVING, TEXAS, WHICH WAS SUBMITTED UNDER MDR NUMBER 3016438761-2021-00016-00. ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER MDR NUMBER 3016438761-2021-00016-00.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS FOR SEVERAL PATIENTS ON AN ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 1.6-2.6 MG/DL): SAMPLE ID: (B)(6) INITIAL RESULT WAS 3.6, REPEAT WAS 1.3 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510004 MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ABBOTT GMBH 03P6822 01964UN20 00380740161620

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C4000 INTGR, 02P24-40, C402043| ARC C4000 INTGR, 02P24-40, C402043