BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 15327274 · Received August 31, 2022

    Report

    Report Number
    3016438761-2022-00393
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    June 22, 2022
    Report Date
    August 31, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). THE INITIAL REPORT WAS SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3005094123-2022-00137-01 (A.I.D.D LONGFORD, LONGFORD AS MANUFACTURING SITE) WITH SUSPECT MEDICAL DEVICE OF ARCHITECT STAT HIGH SENSITIVE TROPONIN-I, LIST 3P25. AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED TO ARCHITECT I1000SR PROCESSING MODULE, LIST 1L86 (IRVING, TX AS MANUFACTURING SITE), WHICH IS UNDER THIS REPORT. DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ASSY, VACUUM PUMP, COMPLETE (ROHS) _PART NUMBER 7-200612-06, WHICH RESOLVED THE ISSUE. A REVIEW OF THE ARCHITECT, SERIAL NUMBER (SN) (B)(4), SERVICE HISTORY DID NOT REVEAL ANY ADDITIONAL CAUSES AND NO OTHER REPORTS OF DISCREPANT OR INCONSISTENT PATIENT RESULTS HAVE BEEN RECEIVED SINCE THE FSR REPLACED THE PART. A REVIEW OF THE ARCHITECT (B)(4) INSTRUMENT SERVICE HISTORY, IDENTIFIED NO CONTRIBUTING FACTORS TO THE DISCREPANT RESULT. A REVIEW OF THE ARCHITECT I, PROCESSING MODULE TRACKING, AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULT DESCRIBED IN THIS COMPLAINT. A REVIEW OF HISTORICAL DATA FOR THE PART (7-200612-06) REVEALED NO TRENDS OR SYSTEMIC ISSUES. A REVIEW OF THE ARCHITECT SYSTEM OPERATIONS MANUAL SHOWS ADEQUATE INFORMATION FOR OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING FOR THE REPORTED ISSUE. ARCHITECT I SYSTEM SERVICE AND SUPPORT MANUAL CONTAINS ADEQUATE INFORMATION FOR THE REMOVAL AND REPLACEMENT OF THE LISTED PARTS. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I1000SR, SN (B)(4) OR ASSY, VACUUM PUMP, COMPLETE (ROHS).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE:ON (B)(6) 2022, SID (B)(6), INITIAL=63.6 PG/ML /REPEATED=1.7 PG/ML LABORATORY REFERENCE RANGE FOR TROPONIN= > 34.2 PG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068465 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1L86-01 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown RGT ARCH TROPONIN 100T, 03P25-27, 38596UD00.