BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 5923084 · Received September 1, 2016

    Report

    Report Number
    1628664-2016-00225
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    August 2, 2016
    Report Date
    May 5, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. A VARIETY OF PARTS WERE REPLACED, ADJUSTED, AND/OR CLEANED ON MULTIPLE OCCASIONS ON THE ARCHITECT C16000. A SPECIFIC SINGULAR CAUSE FOR THE INCONSISTENT SODIUM RESULTS WAS NOT IDENTIFIED. UNDERLYING SAMPLE INTEGRITY AND/OR HANDLING ISSUES WERE IDENTIFIED AS CONTRIBUTING FACTORS. THE INCONSISTENT SODIUM RESULTS WERE ADDRESSED BY PERFORMING NORMAL MAINTENANCE AND TROUBLESHOOTING IN ACCORDANCE WITH CURRENT PRODUCT LABELING IN THE ARCHITECT SYSTEM OPERATIONS MANUAL AND ARCHITECT C16000 SYSTEM SERVICE AND SUPPORT MANUAL. BASED ON ALL AVAILABLE INFORMATION, THE ARCHITECT C16000 ANALYZER PERFORMED AS INTENDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AT THE CUSTOMER SITE. HOWEVER, NO SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IN PROCESS.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSELY DEPRESSED SODIUM RESULTS THAT REPEATED IN THE NORMAL RANGE WHEN PROCESSING ON THE ARCHITECT C16000 ANALYZER. ID (B)(6) GENERATED SODIUM OF 119 MMOL/L THAT REPEATED 142, 135, 142 MMOL/L. ID (B)(6) GENERATED SODIUM OF 112 AND 120 MMOL/L THAT REPEATED 135 AND 135 MMOL/L. ID (B)(6) GENERATED SODIUM OF 116 MMOL/L BUT REPEATED 138 MMOL/L. THE ACCOUNT USES A SODIUM REFERENCE RANGE OF 135 TO 145 MMOL/L. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572862 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM, ICT DILUENT LIST 02P32-50