BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 5333019 · Received December 29, 2015

    Report

    Report Number
    1628664-2015-00343
    Event Type
    Malfunction
    Date Received
    December 29, 2015
    Date of Event
    October 22, 2015
    Report Date
    January 8, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND CLEANED ALL THE CUVETTE WASHER NOZZLES AND CHECKED THE CUVETTE WASHER NOZZLE TUBING. THE FSE IDENTIFIED THE LIKELY CAUSES TO BE NOZZLE NO. 6A TUBING (PN 7-203112-01) AND NOZZLE NO. 6B TUBING (PN 7-203113-01) WHICH WERE LEAKING. THE FSE RESOLVED THE ISSUE BY RECONNECTING AND RESEATING THE TUBING. THERE WERE NO INJURIES OR EXPOSURES REPORTED DUE TO THE LEAKING NOZZLES. SUBSEQUENT INSTRUMENT OPERATIONS WERE ACCEPTABLE. 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 SYSTEMS OPERATIONS MANUAL AND THE ARCHITECT C16000 SYSTEM SERVICE AND SUPPORT MANUAL CONTAIN 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 NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. THE ISSUE WAS ADDRESSED THROUGH STANDARD TROUBLESHOOTING PROCEDURES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE (SID (B)(6) 2015) GENERATED AN INITIAL ARCHITECT CLIN CHEM CREATININE ASSAY RESULT OF 343.1 UMOL/L (3.88 MG/DL). THE RESULT WAS QUESTIONED BY THE PATIENT'S PHYSICIAN AS THE PATIENT DID NOT EXHIBIT ANY SIGNS OF RENAL DYSFUNCTION. THE SAMPLE WAS RETESTED WITH A RESULT OF 52 UMOL/L (0.6 MG/DL). A SECOND PATIENT SAMPLE (SID (B)(6) 2015) GENERATED AN INITIAL RESULT OF 255.5 UMOL/L (2.89 MG/DL) THAT RETESTED AT 73.4 UMOL/L (0.8 MG/DL). THE CUSTOMER PERFORMED A PRECISION CHECK ON SEVERAL ASSAYS WITH ACCEPTABLE RESULTS. THE CUSTOMER REPORTS A THIRD SAMPLE (SID (B)(6)) ALSO EXHIBITED DISCREPANT CREATININE RESULTS, BUT THE CUSTOMER DID NOT PROVIDE ANY VALUES. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856611 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1