BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 12093438 · Received June 30, 2021

    Report

    Report Number
    3016438761-2021-00237
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 18, 2021
    Report Date
    July 15, 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

    SERVICE REVIEWED THE INSTRUMENT LOGS AND DETERMINED AERO CUV SEG (09D32-05) TO BE DIRTY. THE CUVETTES WERE CLEANED, AND THE ISSUE WAS RESOLVED. A REVIEW OF THE ANALYZER¿S SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE COMPLAINT ISSUE. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE AERO CUV SEG DID NOT IDENTIFY ANY TRENDS OR ISSUES. A REVIEW OF TRACKING AND TRENDING DATA FOR ARCHITECT C16000 DID NOT IDENTIFY ANY SYSTEMIC ISSUES OR TRENDS. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT C16000 PROCESSING MODULE (B)(6).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED CALCIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 1.5 MMOL/L, REPEAT = 2.19 MMOL/L, REPEAT ON A DIFFERENT ANALYZER = 2.19 MMOL/L. THE CUSTOMER PROVIDED ADDITIONAL DATA THAT WAS FOR TROUBLESHOOTING PURPOSES ONLY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990383 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 CC CALCIUM, 03L79-21,| CC CALCIUM, 03L79-21,| CC CALCIUM, 03L79-21,