BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 5743549 · Received June 22, 2016

    Report

    Report Number
    1628664-2016-00174
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Date of Event
    May 29, 2016
    Report Date
    May 1, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE WAS DISPATCHED TO THE ACCOUNT AND PERFORMED MULTIPLE TROUBLESHOOTING STEPS, INCLUDING CLEANING THE ARCHITECT C16000 ANALYZER ICT REFERENCE CUP (ROHS) (PART NUMBER 2-201664-02) THAT WAS DESIGNATED AS THE LIKELY CAUSE OF THE ISSUE. NO SUBSEQUENT DISCREPANT OR ERRATIC RESULTS WERE REPORTED AFTER THE CLEANING WAS COMPLETED. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE AND THE SERVICE AND SUPPORT MANUAL ADDRESSES TROUBLESHOOTING, REMOVAL, AND REPLACEMENT OF THE ICT REFERENCE CUP (ROHS) (PART NUMBER 2-201664-02). THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, THE ANALYZER PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THE DEVICE DID NOT PERFORM AS INTENDED. HOWEVER, NO SYSTEMATIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 STATED THAT FALSELY LOW PATIENT VALUES FOR SODIUM RESULTS WERE GENERATED USING THE ARCHITECT C16000 ANALYZER ICT MODULE. (B)(6). SODIUM (NA) INITIAL 101, REPEAT ON ANOTHER ANALYZER 139 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED, AND NO UNNECESSARY TREATMENT WAS GIVEN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394931 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR