BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 11320772 · Received February 12, 2021

    Report

    Report Number
    3016438761-2021-00047
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    January 25, 2021
    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
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SERVICE INSPECTED THE ANALYZER AND DETERMINED THAT THE AERO CUV SEG LIST NUMBER 09D32-05 WAS THE LIKELY CAUSE OF THE DEPRESSED RESULTS. SERVICE REPLACED THE AERO CUV SEG TO RESOLVE THE ISSUE. A REVIEW OF THE ANALYZER SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER OCCURRENCES OF DISCREPANT RESULTS DOCUMENTED AFTER THE AERO CUV SEG WAS REPLACED. A REVIEW OF MANUFACTURING DOCUMENTATION AND TRENDING DATA FOR THE AERO CUV SEG IDENTIFIED NO ISSUES OR TRENDS. A REVIEW OF TRACKING AND TRENDING DATA IN THE PRODUCT MONITORING REVIEW FOR CLINICAL CHEMISTRY SYSTEMS REVEALED NO SYSTEMIC ISSUES OR TRENDS RELATED TO THE DISCREPANT RESULT ISSUE DESCRIBED IN THIS COMPLAINT. THE ERRATIC RESULT RATES WERE REVIEWED AND ARE WITHIN ACCEPTABLE LIMITS. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C16000 ANALYZER WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED A FALSELY DEPRESSED CALCIUM RESULT WHILE USING THE ARCHITECT C16000 ANALYZER. SAMPLE ID SLZ03149301 GENERATED AN INITIAL RESULT OF 2.69 MG/DL AND REPEAT RESULT OF 8.54 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. .

    Description of Event or Problem · 1

    HE CUSTOMER OBTAINED A FALSELY DEPRESSED CALCIUM RESULT WHILE USING THE ARCHITECT C16000 ANALYZER. SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 2.69 MG/DL AND REPEAT RESULT OF 8.54 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218131 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, 42222UN20| CC CALCIUM, 03L79-21, 42222UN20| CC CALCIUM, 03L79-21, 42222UN20