BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 13413660 · Received February 1, 2022

    Report

    Report Number
    3016438761-2022-00047
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    August 2, 2021
    Report Date
    March 29, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DURING THE SUBSEQUENT SITE VISIT BY THE FIELD SERVICE ENGINEER (FSE) THE ANALYZER (ARCHITECT SERIAL NUMBER (B)(6)) WAS INSPECTED, VARIOUS DIAGNOSTIC CHECKS OF THE SYSTEM AND MULTIPLE PARTS REPLACEMENTS WERE PERFORMED. A REVIEW OF THE ANALYZER SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER OCCURRENCES OF DISCREPANT RESULTS AFTER THE SITE VISIT BY THE FSE. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES SAMPLE RESULT OBSERVED PROBLEMS FOR ERRATIC/DISCREPANT RESULTS. A REVIEW OF THE IMMUNOASSAYS SYSTEMS TRACKING, AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULT DESCRIBED IN THIS COMPLAINT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT B12 RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2021 SID E344043808 = 364 PG/ML< REPEATED ON (B)(6) 2021 = 274 PG/ML. NORMAL RANGE: 345-1485 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488544 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC B12 RGT, 07K61-37, 23108UI00| ARC B12 RGT, 07K61-37, 23108UI00