BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 7538810 · Received May 23, 2018

    Report

    Report Number
    1628664-2018-00203
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Report Date
    June 7, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN ABBOTT FIELD SERVICE ENGINEER WAS DISPATCHED TO THE ACCOUNT AND FOUND THE ANALYZER TRIGGER AND PRETRIGGER VALVES WERE LEAKING AND THE MANIFOLD NEEDED TO BE CLEANED. THE CAUSE OF THE LEAKING WAS FOUND TO BE THE TWO VALVES THAT WERE REPLACED [PART 7-200607-01 VALVE, BYPASS, 2 WAY OTHER SYSTEMS AND PART 7-77612-03 VALVE, MANIFOLD KIT]. THE MANIFOLD WAS CLEANED AND THE ANALYZER WAS RETURNED TO NORMAL OPERATION. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A COMPLAINT TEXT REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, DEVICE HISTORY REVIEW, AN INSTRUMENT SERVICE REVIEW, AND LABELING REVIEW. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. SERVICE HISTORY REVIEW IDENTIFIED NO CONTRIBUTING FACTORS TO THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS EVALUATION, NO SYSTEMIC ISSUE WAS IDENTIFIED AND NO PRODUCT DEFICIENCY WAS FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED REPEAT CARDIAC TROPONIN I (CTNI). RESULTS WHILE USING THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED. PATIENT INITIAL 15.3 PG/ML, REPEAT 55.2 PG/ML. PATIENT INITIAL 2.2 PG/ML, REPEAT 20.0 PG/ML. PATIENT INITIAL 0.06 PG/ML, REPEAT 18.4 PG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380792 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I| ARCHITECT STAT HIGH SENSITIVE TROPONIN-I| LIST NUMBER 3P25-26| LIST NUMBER 3P25-26| LOT NUMBER 83393UI00| LOT NUMBER 83393UI00