BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 3222357 · Received July 12, 2013

    Report

    Report Number
    1628664-2013-00175
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CEM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FIELD SERVICE PERFORMED PREVENTIVE MAINTENANCE ON THE INSTRUMENT AND REPLACED VARIOUS FLUIDICS PARTS. THE SAMPLE VALVE WAS INTERMITTENTLY STICKING IN THE OPEN POSITION AND ADDITIONAL SERVICE WAS DONE FOR A LEAK AT THE REAR OF THE INSTRUMENT. SERVICE ADDRESSED THE LEAKING AND THE SAMPLE WASH VALVE WAS THEN CLOSING. OTHER CONNECTIONS ASSOCIATED WITH THE ICT WERE CHECKED AND RESEATED AND THE ISSUE WAS CONSIDERED RESOLVED. SERVICE TICKET HISTORY REVIEW DID NOT REVEAL ANY OTHER ISSUES THAT MAY HAVE CONTRIBUTED TO THE CURRENT COMPLAINT. NO SINGLE DEFINITIVE CAUSE OF THE ERRATIC RESULTS WAS IDENTIFIED. VARIOUS PARTS ARE COMMONLY REPLACED DURING PREVENTIVE MAINTENANCE AND TO ADDRESS FLUIDICS ISSUES. NO ADVERSE TRENDS WERE IDENTIFIED WITH RESPECT TO THE LISTED PARTS OR THE INSTRUMENT. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY OF THE SYSTEM WAS NOT IDENTIFIED. THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES. COMPONENTS ARE INSPECTED AS PART OF ROUTINE MAINTENANCE AS DESCRIBED IN THE OPERATIONS MANUAL. TROUBLESHOOTING ASSISTANCE IS ALSO AVAILABLE IN CURRENT LABELING FOR ERRATIC RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED POTASSIUM IMPRECISION WHILE TESTING PATIENT SAMPLES ON THE ARCHITECT C16000 ANALYZER. AN INITIAL RESULT OF APPROXIMATELY 6.5 MMOL/L RETESTED AT 4.5 MMOL/L. THE ARCHITECT SYSTEM IS SET UP TO RETEST ANY POTASSIUM RESULT OF 6.1 MMOL/L OR HIGHER. THE INITIAL RESULT WAS NOT REPORTED OUT OF THE LABORATORY. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321804 ARCHITECT C16000 SYSTEM CEM ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1