BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 9500906 · Received December 20, 2019

    Report

    Report Number
    1628664-2019-00770
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Report Date
    February 11, 2020
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K981791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON JAN 17, 2020 THE SUSPECT MEDICAL DEVICE WAS UPDATED FROM LN 03P68-31 LOT 69365UN18 TO ARCHITECT C4000 ANALYZER LN 02P24-40 SN (B)(6) , BOTH MANUFACTURERED IN IRVING, TEXAS. SECTIONS D1, D2, D4 WERE UPDATED TO DOCUMENT THIS CHANGE. 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 FIELD SERVICE REPRESENTATIVE INSPECTED THE INSTRUMENT, DRAINED THE DEGASSER CANNISTER, CLEANED THE WATER BATH, MANUALLY CLEANED THE CUVETTES, REBUILT THE VACUUM PUMP, AND REPLACED A DIRTY/CLOGGED WATER BATH CHECK VALVE. THE ISSUE WAS RESOLVED BY REPLACING THE CHECK VALVE, WATER BATH FILL (PART NUMBER 7-203638-01). 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 RESULT ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 9.5 MG/DL, REPEAT 2.1. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300728 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 69365UN18

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C4000 ANALYZER.| LN 02P24-40 SN (B)(6) .| LN 03P68-31 LOT 69365UN18.| MAGNESIUM REAGENTS.