BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2895104 · Received January 3, 2013

    Report

    Report Number
    1628664-2013-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 12, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGS
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE WAS DISPATCHED TO THE ACCOUNT. ACTIONS TAKEN TO RESOLVE THE ISSUE INCLUDED REPLACING THE FOUR ICT 1 ML SYRINGES AND THEIR CORRESPONDING ICT CHECK VALVES, THE ICT PINCH TUBING, AND THE ICT MODULE OF LOT 120302 WHICH HAD EXPIRED ON 12/02/2012. THE ICT ASSAYS THEN CALIBRATED SUCCESSFULLY AND GENERATED ACCEPTABLE PRECISION. NO FURTHER ICT RELATED ISSUES HAVE BEEN REPORTED. THE CUSTOMER MAINTENANCE LOG WAS REVIEWED AND IT SHOWED THAT SEVERAL QUARTERLY MAINTENANCE ITEMS WERE OVERDUE INCLUDING MAINTENANCE FOR THE SAMPLE SYRINGE, WASH SYRINGE, REAGENT SYRINGE, AND REPLACEMENT OF THE ICT 1 ML SYRINGES AND ICT ASPIRATION CHECK VALVES. THE MAINTENANCE LOG ALSO INDICATES THE SUSPECT ICT MODULE MAY HAVE BEEN IN USE FOR 7 MONTHS. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ICT SAMPLE DILUENT PACKAGE INSERT WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE. A SINGULAR SPECIFIC CAUSE FOR THE CUSTOMER'S ISSUE WAS NOT IDENTIFIED. PROBABLE CAUSES THAT COULD NOT BE RULED OUT INCLUDE THE WORN 1 ML SYRINGES, ICT CHECK VALVES, AND ICT PINCH TUBING THAT WERE REPLACED SIMULTANEOUSLY WITH THE EXPIRED ICT MODULE. REPLACEMENT OF THESE WORN PARTS RESOLVED THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION/DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    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 THE ARCHITECT C8000 ANALYZER GENERATED A DECREASED SODIUM RESULT OF 101 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER C8000 ANALYZER AND A RESULT OF 137 MMOL/L WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546 ARCHITECT C8000 SYSTEM JGS ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MODULE 9D28-03, SN (B)(4)| ICT MODULE 9D28-03, SN (B)(4)