BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 2730675 · Received September 6, 2012

    Report

    Report Number
    1628664-2012-00390
    Event Type
    Injury
    Date Received
    September 6, 2012
    Date of Event
    August 23, 2012
    Report Date
    August 23, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CGZ
    PMA / PMN Number
    K980367
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    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

    AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND INSPECTED THE ANALYZER. THE FSE FOUND THAT INTEGRATED CHIP TECHNOLOGY (ICT) ASPIRATION TUBING WAS NOT INSTALLED PROPERLY BY THE CUSTOMER. THE TUBING WAS CONNECTED TO THE PINCH VALVE BY THE TUBING SLEEVE INSTEAD OF THE TUBING ITSELF. THE FSE REPLACED THE TUBING AND SUBSEQUENT INSTRUMENT OPERATION AND TEST RESULTS WERE ACCEPTABLE. NO FURTHER ISSUES WERE DISCOVERED. 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 SYSTEM OPERATIONS MANUAL CONTAINS INFORMATION TO ADDRESS THE CUSTOMER ISSUE. BASED UPON THE AVAILABLE DATA AND THE RESULTS OF THE CURRENT EVALUATION A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY INCREASED RESULTS FOR THE CHLORIDE ASSAY GENERATED ON THE ARCHITECT C4000 ANALYZER. ONE PATIENT ADMITTED DUE TO SHORTNESS OF BREATH GENERATED A RESULT OF 133 MMOL/L AND WAS ALLEGEDLY TREATED BASED ON THIS ELEVATED RESULT. CONTROLS WERE WITHIN SPECIFICATIONS. THE SAMPLE GENERATED A CHLORIDE RESULT OF 106 MMOL/L ON THE ISTAT SYSTEM AND THE FOLLOWING DAY AN ISTAT CHOLRIDE RESULT OF 97 MMOL/L WAS GENERATED ON THE SAME SAMPLE. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C4000 ANALYZER CGZ ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other ICT MODULE LN: 09D28-03 SN: 120629| ICT CONC. DIL LN: 02P32-10 LOT: 52804UN12| ICT ASP PUMP TUBING LN:7-205555-01| ICT MOD LN: 09D28-03 SN: (B)(4)| ICT CONC. DIL LN: 02P32-10 LOT: 52804UN12| ICT PROBE LN: 09D63-03