BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 12633380 · Received October 14, 2021

    Report

    Report Number
    3016438761-2021-00368
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 23, 2021
    Report Date
    October 25, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER REPLACED THE SYRINGES, THE 1 ML SYRINGE (LN 09D41-03), WHICH RESOLVED THE ISSUE. A REVIEW OF THE ARCHITECT C8000 PROCESSING MODULE, SERIAL NUMBER(B)(6) SERVICE HISTORY FOUND NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. A REVIEW OF TRACKING AND TRENDING OF THE ARCHITECT C8000 PROCESSING MODULE OR THE 1 ML SYRINGE, DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. A REVIEW OF THE C801597 SERVICE HISTORY WAS PERFORMED AND NO ADDITIONAL ERRATIC RESULTS PRE- OR POST THE CURRENT COMPLAINT WERE IDENTIFIED. HE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM. THE OPERATIONS MANUAL ALSO ADDRESSES TROUBLESHOOTING OF DEPRESSED CONCENTRATION AND ERRATIC SAMPLE RESULTS AND PROVIDES THE REMOVAL, THE REPLACEMENT, AND THE VERIFICATION PROCEDURES FOR THE 1 ML SYRINGE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT C8000 PROCESSING MODULE, SERIAL NUMBER (B)(6) , OR THE1 ML SYRINGE.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER = SID=(B)(6). THERE WAS NO FURTHER PATIENT INFORMATION 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 FALSELY DECREASED CALCIUM RESULTS ON ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL=5.6 MG/DL /REPEATED=9.9 MG/DL AND 9.9 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528667 ARCHITECT C8000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 CC CALCIUM(1500T), 03L79-22, (B)(4).| CC CALCIUM(1500T), 03L79-22, (B)(4).| CC CALCIUM(1500T), 03L79-22, 03593UN21