BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 9039099 · Received September 13, 2019

    Report

    Report Number
    1628664-2019-00611
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Report Date
    September 23, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 THE VALVE, BYPASS, 2 WAY (ROHS) (PN 7-200607-01). BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 A FALSE NEGATIVE TROPONIN RESULT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING INFORMATION WAS PROVIDED: ON (B)(6) 2019: PATIENT WAS BROUGHT IN TO EHS. TROPONIN RESULT WAS 0 NG/L. PATIENT WAS SENT HOME AS THE CUSTOMER USES A CUTOFF OF 2.9 NG/L. ON (B)(6) 2019: PATIENT WAS BACK AT THE HOSPITAL. TROPONIN WAS MEASURED AND THE RESULTS IS 6000 NG/L. SAMPLE FROM (B)(6) WAS REANALYZED AND THE RESULT IS 1400 NG/L. NO FURTHER PATIENT INFORMATION OR DETAILS ON IMPACT WERE AVAILABLE. NO NEGATIVE IMPACT TO PATIENT MANAGEMENT IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812322 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1