BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY MAGNESIUM

    MDR report key: 3112263 · Received May 14, 2013

    Report

    Report Number
    1628664-2013-00130
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGJ
    PMA / PMN Number
    K981791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES, AND THE REAGENT LABELING. A REVIEW OF THE COMPLAINT RECORDS FOR THE AFFECTED REAGENT LOT DID NOT IDENTIFY ANY COMPLAINT TRENDS RELATING TO THIS ISSUE. A REVIEW OF PRODUCT LABELING CONCLUDED THAT THE MAGNESIUM REAGENT PACKAGE INSERT AND ARCHITECT SYSTEM OPERATIONS MANUAL HAVE ADEQUATE LABELING FOR SAMPLE HANDLING AND TROUBLESHOOTING ERRATIC RESULTS. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR CLINICAL CHEMISTRY MAGNESIUM, LIST NUMBER 07D70, LOT NUMBER 08975UN12.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY INCREASED MAGNESIUM RESULTS ON A PATIENT (ID (B)(4)). RESULTS PROVIDED WERE: >7.8 MG/DL/ REPEAT 1.9 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUT FROM THE LAB. THE CUSTOMER STATED IT IS THEIR FACILITY'S POLICY TO RERUN ANY MAGNESIUM RESULTS THAT ARE > 2.5 MG/DL. ALL QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGES. THERE IS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE ALSO WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211775 CLINICAL CHEMISTRY MAGNESIUM JGJ ABBOTT MANUFACTURING INC 08975UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C8000 SYSTEM, LIST # 01G06-11| SERIAL # (B)(4)| SERIAL # (B)(4)| ARCHITECT C8000 SYSTEM, LIST # 01G06-11