BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 19710673 · Received July 10, 2024

    Report

    Report Number
    3016438761-2024-00395
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740100599
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED TOTAL BILIRUBIN RESULTS ON AN ARCHITECT C16000 PROCESSING MODULE, SERIAL NUMBER (B)(6), INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. TRENDING REVIEW DETERMINED NO RELATED TREND FOR ELEVATED RESULTS FOR THE PRODUCT. BASED ON THE INFORMATION PROVIDED, THE CUSTOMER REPORTED HAVING CALIBRATED AND REPLACED THE R1 PROBE. THE ISSUE WAS RESOLVED BY REPLACING THE C16 RGT PR(L)ROHS, LIST NUMBER 09D48-03. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. MANUFACTURING DOCUMENTATION WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE ID (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS FOR SEVERAL PATIENTS ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.2-1.2 MG/DL): SAMPLE ID (B)(6) INITIAL RESULT WAS 8.5, REPEAT WAS 0.38 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS 9.5, REPEAT WAS 0.42 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS 10.5, REPEAT WAS 0.46 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS FOR SEVERAL PATIENTS ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.2-1.2 MG/DL): SAMPLE ID (B)(6) INITIAL RESULT WAS 8.5, REPEAT WAS 0.38 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS 9.5, REPEAT WAS 0.42 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS 10.5, REPEAT WAS 0.46 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040534 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740100599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CC TOTAL BILI (3840T), 06L45-42, 64556UQ07| CC TOTAL BILI (3840T), 06L45-42, 64556UQ07