BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 6309035 · Received February 7, 2017

    Report

    Report Number
    1628664-2017-00028
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 17, 2017
    Report Date
    March 30, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740003746
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND INSPECTED THE ARCHITECT C4000 ANALYZER. THE FSE ADJUSTED THE REAGENT PROBE, THE SAMPLE PROBE TUBING, THE MIXER AND THE REAGENT WASH CUP. THE FSE DETERMINED THAT THE REAGENT WASH CUP (PART 7-32132-03) WAS THE MOST LIKELY CAUSE OF THE CUSTOMER ISSUE. SUBSEQUENT INSTRUMENT OPERATIONS WERE ACCEPTABLE. NO RETURNS WERE AVAILABLE FROM THE CUSTOMER SITE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO RELATED ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT C4000 SYSTEM SERVICE AND SUPPORT MANUAL PROVIDE INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. HOWEVER, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS FALSELY ELEVATED POTASSIUM ASSAY RESULTS GENERATED ON AN ARCHITECT C4000 ANALYZER. THE FOLLOWING WAS PROVIDED: SID (B)(6) ON (B)(6) 2017= 7.0 MMOL/L THAT RETESTED AT 4.6 MMOL/L. SID (B)(6) ON (B)(6) 2017= 9.4 MMOL/L THAT RETESTED AT 4.1 MMOL/L. CONTROLS WERE WITHIN SPECIFICATIONS. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO KNOWN IMPACT TO PATIENT MANAGEMENT REPORTED. PREVENTIVE MAINTENANCE ON THE ANALYZER WAS PERFORMED ON 13 JANUARY 2017. THE CUSTOMER USES A NORMAL REFERENCE RANGE FOR THIS ASSAY OF 3.5-5.1 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90262 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740003746

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT SERUM CALIBRATOR LN: 01E46-03| LOT NO. 42745UN16