BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 11127805 · Received January 6, 2021

    Report

    Report Number
    3016438761-2021-00007
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 14, 2020
    Report Date
    February 26, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: SAMPLE ID ADDED, (B)(6). THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING AND REPLACED THE BELLOWS, BELLOWS ONLY (ROHS) PART NUMBER 2-89054-02 DUE TO LEAKING. A REVIEW OF SERVICE HISTORY FOR THE ARCHITECT C16000 SERIAL NUMBER (B)(6) REVEALED NO ADDITIONAL DISCREPANT RESULTS REPORTED, NOR DID IT IDENTIFY ANY CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING FOR THE BELLOWS, BELLOWS ONLY (ROHS) PART NUMBER 2-89054-02 DID NOT IDENTIFY ANY TRENDS. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT C16000 DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE INSTRUMENT PART OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE BELLOWS, BELLOWS ONLY (ROHS) PART NUMBER 2-89054-02 OR THE ARCHITECT C16000 SERIAL NUMBER (B)(6) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. NO PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER GENERATED FALSELY ELEVATED ENZYMATIC CREATININE RESULTS WHILE USING THE ALINITY C ENZYMATIC CREATININE (LIST NUMBER LN 8L24-31). THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT REPORTED OUT OF THE LAB, 606 UMOL/L, REPEAT 71.7 UMOL/L AND REPEAT AT ANOTHER FACILITY 70 UMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23941 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 MLTGNT ENZY CREAT, 08L24-31, 00028Y600| MLTGNT ENZY CREAT, 08L24-31, 00028Y600