BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 7149207 · Received December 27, 2017

    Report

    Report Number
    1628664-2017-00535
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    December 9, 2017
    Report Date
    February 20, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K981791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018 THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM MAGNESIUM REAGENTS LN 7D70-21 TO ARCHITECT C4000 ANALYZER LN 02P24-40 SN (B)(4) WHICH ARE BOTH MANUFACTURED IN (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED BY ADJUSTING THE WASH CUP VOLUMES AND EDITED THE MAGNESIUM SMART WASH TO MATCH THE MAGNESIUM PACKAGE INSERT AND REPLACING THE SAMPLE AND R1 SYRINGE VALVES (PART NUMBER 7-202518-01). BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MG/DL): PATIENT 2 INITIAL 3.4 REPEAT 1.2, 1.2, 1.2. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927512 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER, JJE ABBOTT MANUFACTURING INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1