BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1860707 · Received October 7, 2010

    Report

    Report Number
    1628664-2010-00357
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER FOUND THE R1 REAGENT PROBE WAS BENT ON THEIR C8000 (B)(4). THE CUSTOMER REPLACED AND CALIBRATED THE BENT R1 REAGENT PROBE TO RESOLVE THE ISSUE. THE CUSTOMER DISCARDED THE BENT PROBE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT OPERATIONS MANUAL CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. ALTHOUGH THE DAMAGED R1 REAGENT PROBE CAUSED ABERRANT RESULTS TO BE GENERATED, THE DAMAGE WAS NOT SUFFICIENT TO GENERATE ANY ERRORS. BASED ON THE AVAILABLE INFORMATION, A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. REVIEW OF COMPLAINT TRACKING AND TRENDING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ELEVATED PATIENT RESULTS GENERATED BY THE ARCHITECT C8000 ANALYZER WERE RELEASED FROM THE LAB AND QUESTIONED BY A PHYSICIAN. THE CUSTOMER PROVIDED THE FOLLOWING INITIAL AND CORRECTED RESULTS: INITIAL RESULT CORRECTED RESULTSODIUM 161 141 MMOL/LTHE CUSTOMER STATED THAT NO FURTHER PATIENT INFORMATION WOULD BE MADE AVAILABLE. UPON TROUBLESHOOTING, THE CUSTOMER FOUND A BENT R1 PROBE AND IS CONCERNED THAT NO ERROR MESSAGE WAS GENERATED AS A RESULT. THE CUSTOMER REPLACED THE PROBE AND ALL CONTROLS WERE WITHIN SPECIFICATION. THE CORRECTED RESULTS WERE THEN GENERATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C8K RGT PROBE LN: 1G47-03| ARC C8K RGT PROBE LN: 1G47-03