BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 9105371 · Received September 23, 2019

    Report

    Report Number
    1628664-2019-00628
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    August 23, 2019
    Report Date
    September 20, 2021
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ABBOTT FIELD SERVICE (FS) INVESTIGATED THE ISSUE ON SITE. FS OBSERVED THE ICT MODULE EXPIRED ON 30AUG2019 AND THE MIXERS WERE NOT FUNCTIONING PROPERLY. THE ICT MODULE AND MIXERS WERE REPLACED BY FS. A REVIEW OF THE C802496 SERVICE HISTORY FOUND NO ADDITIONAL LIKELY CAUSES AND NO ADDITIONAL REPORTS OF INCONSISTENT OR ERRATIC RESULTS HAVE BEEN RECEIVED SINCE FS ADDRESSED THE ISSUE. A REVIEW OF HISTORICAL DATA FOR THE ICT MODULE (LN 09D28-03) AND MIXERS (LN 09D59-02) REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS REVEALED THAT THE CALCULATED ERRATIC RATES FOR THE ARCHITECT C4000, C8000, AND THE C16000 SYSTEMS WERE ALL BELOW THE UPPER CONTROL LIMIT AND FOUND NO SYSTEMIC ISSUES OR TRENDS FOR THE ISSUE ASSOCIATED WITH THIS TICKET (ERRATIC/DISCREPANT RESULTS). LABELING WAS REVIEWED AND CONTAINS ADEQUATE INFORMATION ON MAINTENANCE AND TROUBLESHOOTING OF ERRATIC RESULTS. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE INADVERTENTLY WAS SUBMITTED ON MDR NUMBER 1628664-2019-00628 AND IS BEING SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3016438761-2021-00334 FOR CORRECTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY DECREASED POTASSIUM RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED (NORMAL RANGE: (3.5-5.1 MEQ/L): SID (B)(6) ON (B)(6) 2019 = 2.4 / 3.9 / 3.9 / 3.9 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899602 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 1G06-11 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1