BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 11797195 · Received May 10, 2021

    Report

    Report Number
    3016438761-2021-00178
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 18, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER AND OBSERVED AN ASPIRATION ISSUE AT THE CUVETTE WASHER NOZZLE 1B. THE FSR RESOLVED THE ISSUE BY REPLACING WASH NOZZLE 1B AND THE HIGH CONCENTRATION WASTE PERISTALTIC PUMP TUBING. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE CAUSE OF THE ISSUE WAS IDENTIFIED AS THE NOZZLE PAIRS, 1,4,5,WASTE & DI (ROHS) AND TUBING, PERISTALTIC HEAD (ROHS). THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED ZERO (0) ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC RESULTS. A REVIEW OF TRACKING AND TRENDING DID NOT REVEAL ANY TRENDS FOR THE NOZZLE PAIRS, 1,4,5, WASTE & DI (ROHS) AND TUBING, PERISTALTIC HEAD (ROHS), OR THE ARCHITECT C16000 SYSTEM. THE ARCHITECT C4000, C8000, AND THE C16000 ERRATIC RESULT RATES WERE WITHIN ACCEPTABLE LIMITS WITH NO TRENDS IDENTIFIED. ADDITIONALLY, LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ARCHITECT SYSTEM OPERATIONS MANUAL (201837-115) AND THE ARCHITECT C16000 SYSTEM SERVICE AND SUPPORT MANUAL (201980-120), PROVIDE ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS AND THE REMOVAL, REPLACEMENT AND VERIFICATION OF NOZZLE PAIRS, 1,4,5,WASTE & DI (ROHS) AND TUBING, PERISTALTIC HEAD (ROHS). BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE NOZZLE PAIRS, 1,4,5, WASTE & DI (ROHS) OR THE TUBING, PERISTALTIC HEAD (ROHS), OR THE ARCHITECT C16000 SYSTEM SERIAL C1601214 WAS IDENTIFIED.THIS FOLLOW UP IS BEING SUBMITTED TO INCLUDE D8 AND H6 INFORMATION PREVIOUSLY SUBMITTED USING THE H10 SECTION IN THEIR RESPECTIVE FIELDS.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. PATIENT IDENTIFIER: MULTIPLE = SID (B)(6). 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 OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR THREE PATIENTS. ON (B)(6) 2021, THE FOLLOWING RESULTS WERE GENERATED: SID (B)(6) INITIAL TOTAL BILIRUBIN RESULT WAS 108.6 MG/L HIGH, REPEATED 4.3 MG/L, BILID 1.965 AND 1.8 MG/L; SID (B)(6) INITIAL TOTAL BILIRUBIN RESULT WAS 133.5 MG/L HIGH, REPEATED 2.121 MG/L LOW, BILID 1.294 AND 1.305 MG/L; SID (B)(6) INITIAL TOTAL BILIRUBIN RESULT WAS 84.3 MG/L, REPEATED 3.9 MG/L, BILID 6.7 MG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693662 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 CC TOTAL BILI (2750T), 06L45-22, 58911UQ01.| CC TOTAL BILI (2750T), 06L45-22, 58911UQ01.