BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2042657 · Received April 6, 2011

    Report

    Report Number
    1628664-2011-00143
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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). REVIEW OF THE ARCHITECT C8000 SYSTEM LOGS DID NOT IDENTIFY ANY ISSUES. CONTROLS WERE WITHIN RANGE FOLLOWING TROUBLESHOOTING, BUT PATIENT RESULTS WERE STILL ERRATIC. FIELD SERVICE DISCOVERED THAT THE AMOUNT OF WATER USED FOR CLEANING THE REAGENT PROBE WAS TOO SMALL AND ADJUSTED THE FLOW. PROPER OPERATION OF THE SYSTEM WAS VERIFIED AFTER ADJUSTING THE WATER FLOW TO THE REAGENT PROBE. QUALITY METRICS AND COMPLAINT TRACKING AND TRENDING WAS REVIEWED. NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO DISCREPANT RESULTS. THE CURRENT COMBINED ERRATIC RESULT RATE FOR AEROSET AND ARCHITECT INSTRUMENTS FALLS BELOW THE ESTABLISHED INTERNAL ABERRANT RESULT RATE FOR ARCHITECT C8000 ESTABLISHED AT PRODUCT LAUNCH. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY OF THE ARCHITECT C8000 SYSTEM WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT FALSELY ELEVATED ARCHITECT MAGNESIUM RESULTS WERE GENERATED FOR PATIENT SAMPLES. AN INITIAL ELEVATED RESULT OF 2.63 MMOL/L RETESTED AT 0.74 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS 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 MAGNESIUM LIST 7D70-21, LOT 40935UN10| MAGNESIUM LIST 7D70-21, LOT 40935UN10