BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 8384049 · Received March 1, 2019

    Report

    Report Number
    1628664-2019-00173
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Report Date
    March 12, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED BY REPLACING MULTIPLE PARTS: PRE TRIGGER PUMP PART NUMBER 7-96345-01, VALVE MANIFOLD KIT PART NUMBER 7-77612-03 AND VALVE, BYPASS, PART NUMBER 7-200607-01. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) TOXO IGG, HBCAB-IGM, CMV IGG, HBSAG AND HIV RESULTS FOR MULTIPLE PATIENTS ON THE ARCHITECT I1000SR ANALYZER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. INSTRUMENT MAINTENANCE INCLUDING REPLACEMENT OF THE SYRINGE AND VORTEXER ON (B)(6) 2019 APPEARS TO HAVE RESOLVED THE ISSUE. THE CUSTOMER CONFIRMS THERE HAVE BEEN NO MORE DISCREPANT DATA AS OF (B)(6) 2019. THE COMPLETE PRODUCT EVALUATION IS STILL IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176841 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1