BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 5391834 · Received January 26, 2016

    Report

    Report Number
    1628664-2016-00023
    Event Type
    Malfunction
    Date Received
    January 26, 2016
    Date of Event
    January 7, 2016
    Report Date
    April 7, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING, AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. 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. A MALFUNCTION OF THE FOLLOWING PARTS WAS IDENTIFIED; 1 ML SYRINGE (PART 09D41-02), TBG, ICT VALVE NO TO WASTE (PART 7-203000-01), VALVE, POPPET SET (PART 09D36-02), AND TUBING, ICT ASPIRATION (PART 7-202639-01) CONCLUSION CODE WAS CORRECTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT PATIENT SODIUM VALUES GENERATED USING THE ARCHITECT C16000 ANALYZER ICT MODULE WERE FALSELY DEPRESSED. THE FOLLOWING DATA WAS PROVIDED (MMOL/L). SID R361456Q INITIAL 118.2, REPEATED 138.7. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48718 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1