BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 PROCESSING MODULE

    MDR report key: 10006420 · Received April 28, 2020

    Report

    Report Number
    3016438761-2020-00056
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Date of Event
    April 6, 2020
    Report Date
    May 18, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE SITE VISIT, THE FIELD SERVICE REPRESENTATIVE REPLACED THE BELLOWS, BELLOWS ONLY (ROHS) (LN 2-89054-02), AND THE 1 ML SYRINGE (LN 09D41-03), WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT C8000, SERIAL NUMBER (B)(4), ANALYZER'S SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER OCCURRENCES OF DISCREPANT RESULTS AFTER THE PARTS WERE REPLACED. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS, TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM, AND TROUBLESHOOTING OF ELEVATED AND ERRATIC SAMPLE RESULTS. A 12-MONTH REVIEW FOR THE BELLOWS SET, INCL ROD & FITTING AND THE FILTER, WATER BATH (ROHS) FOUND NO TRENDS REGARDING THE CURRENT COMPLAINT ISSUE. THE MONTHLY PRODUCT MONITORING REVIEW FOR THE ARCHITECTC8000 PLATFORM, REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULT DESCRIBED IN THIS COMPLAINT. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT C8000 ANALYZER, SN (B)(4), THE BELLOWS, BELLOWS ONLY (ROHS) (LN 2-89054-02), OR THE 1 ML SYRINGE (LN 09D41-03).

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM (MG) RESULTS ON TWO PATIENTS GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: PT#1 ON (B)(6) 2020 INITIAL = 6.49MG/DL (NORMAL RANGE 1.6 TO 2.6MG/DL) / RETEST ON DIFFERENT ANALYZER = 2.25MG/DL. ON (B)(6) 2020 PT#2 INITIAL = 7.83 / RETEST = 1.96MG/DL WHICH MATCHES THE PATIENTS PREVIOUS RESULT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469459 ARCHITECT C8000 PROCESSING MODULE AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT LABORATORIES (IRVING IA/CC) 1G06-11 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1 MAGNESIUM, LN 03P68-22, LOT # 65046UN19| MAGNESIUM, LN 03P68-22, LOT # 65046UN19