BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 16004614 · Received December 19, 2022

    Report

    Report Number
    3016438761-2022-00593
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 29, 2022
    Report Date
    January 25, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001544
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING A FALSE NEGATIVE ARCHITECT TOTAL B-HCG RESULT ON THE ARCHITECT (B)(6), SERIAL NUMBER (B)(6). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR FOUND LEAKING OF THE ASSY, TRIGGER_PRE-TRIGGER HEATER, COMPLETE (ROHS), PART NUMBER 7-200599-02, TUBING, PRE-TRIG PUMP TO HEATER (ROHS), PART NUMBER 7-200119-01, AND TUBING, TRIG PUMP TO HEATER (ROHS), PART NUMBER 7-200122-01, WHICH WERE REPLACED AND RESOLVED THE CUSTOMER¿S COMPLAINT. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<5.00 MIU/ML IS NEGATIVE, >/=25.00 MIU/ML IS POSITIVE): SAMPLE ID (B)(6) INITIAL RESULT WAS <1.20, REPEAT WAS >15,000 MIU/ML. THE SAMPLE WAS DILUTED 1:2 AND THE RESULT WAS 182,994.44 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2710369 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1L86-40 00380740001544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC BHCG RGT (100T), 07K78-25, (B)(6).| ARC BHCG RGT (100T), 07K78-25, (B)(6).