BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 8406470 · Received March 10, 2019

    Report

    Report Number
    1628664-2019-00188
    Event Type
    Malfunction
    Date Received
    March 10, 2019
    Date of Event
    February 14, 2019
    Report Date
    April 1, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K981791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/13/2019 THE SUSPECT MEDICAL DEVICE WAS UPDATED FROM MAGNESIUM REAGENTS LN 03P68-21 LOT 73839UN18 TO THE ARCHITECT C4000 ANALYZER LN 02P24-01 SN C460186, BOTH MANUFACTURED IN IRVING, TEXAS USA. SECTION D 1-11 WAS UPDATED AS NECESSARY: D1 BRAND NAME FROM CLINICAL CHEMISTRY MAGNESIUM TO ARCHITECT C4000 ANALYZER D2 COMMON DEVICE NAME FROM MAGNESIUM TO AUTOMATED CHEMISTRY ANALYZER PRODUCT CODE FROM JGJ TO JJE 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 REPLACING THE CUVETTE WASHER, C4, PART NUMBER 7-205198-01. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MEQ/L): SID (B)(6): INITIAL 9.38, REPEAT 1.16. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199623 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 73839UN18

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C4000 ANALYZER| LN 02P24-01 SN C460186| LN 03P68-21 LOT 73839UN18| MAGNESIUM REAGENTS