BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 10844328 · Received November 16, 2020

    Report

    Report Number
    3016438761-2020-00301
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    October 27, 2020
    Report Date
    January 19, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING WHICH INCLUDED REPLACEMENT OF THE LENS, WATER BATH, INNER, 16 (ROHS) (LN 7-202570-01), WHICH RESOLVED THE ISSUE. THERE WERE NO ADDITIONAL DISCREPANT RESULTS REPORTED ON THE ARCHITECT C16000, SERIAL NUMBER: (B)(6) AFTER REPLACEMENT OF THE LENS, WATER BATH, INNER. A REVIEW OF THE ARCHITECT C16000, SN: (B)(6) SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. A REVIEW OF THE TRACKING AND TRENDING FOR THE ARCHITECT C16000 SYSTEMS FOUND NO SYSTEMIC ISSUES OR TRENDS FOR ERRATIC/DISCREPANT RESULTS. A REVIEW OF HISTORICAL DATA FOR THE VALVE, POPPET SET, LIST NUMBER: 7-202570-01, REVEALED NO TRENDS OR SYSTEMIC ISSUES. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT C16000 SERVICE AND SUPPORT MANUAL, PROVIDE ADEQUATE INFORMATION, TROUBLESHOOTING, AND MAINTENANCE CONCERNING ERRATIC / DISCREPANT RESULTS, INCLUDING, BUT NOT LIMITED TO REPLACING THE LENS, WATER BATH, INNER. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT, SN: (B)(6) OR THE LENS, WATER BATH, INNER, LIST NUMBER: 7-202570-01.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER 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 IMPRECISE RESULTS FOR LDH ON ARCHITECT C16000 PROCESSING MODULE FOR MULTIPLE PATIENTS. THE FEW PATIENT RESULTS PROVIDED WERE: SID (B)(6) INITIAL LDH=425 U/L /REPEATED=185 U/L, SID (B)(6) INITIAL LDH=395 U/L /REPEATED=259 U/L, SID (B)(6) INITIAL LDH=682 U/L /REPEATED=348 U/L. LABORATORY REFERENCE RANGE FOR LDH=125 U/L TO 220 U/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311322 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 CC LDH(1300T), 02P56-22, 82161UN20| CC LDH(1300T), 02P56-22, 82161UN20