BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3813086 · Received May 15, 2014

    Report

    Report Number
    1628664-2014-00100
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW FOR SIMILAR COMPLAINTS, A REVIEW OF SERVICE RECORDS, AND A REVIEW OF LABELING. THE COMPLAINT TEXT INDICATES A FALSE POSITIVE STAT TROPONIN-I RESULT WAS GENERATED FOR A SINGLE PATIENT ON THE ARCHITECT I2000SR (SERIAL NUMBER (B)(4)). A REVIEW OF LABELING DETERMINED THAT THERE IS ADEQUATE INFORMATION RELATED TO HANDLING SPECIMENS AND CONSUMABLES, REQUIRED MAINTENANCE, AND TROUBLESHOOTING TO ADDRESS THE CUSTOMER'S ISSUE. A REVIEW OF THE SERVICE HISTORY FOR SN (B)(4) DID NOT IDENTIFY FURTHER REPORTS OF ERRATIC OR DISCREPANT PATIENT RESULTS. A REVIEW OF COMPLAINTS FOR THE PROBE (LIST NUMBER 08C94-42) AND VALVE, MANIFOLD KIT (PART NUMBER 7-77612-02) DID NOT IDENTIFY ANY ISSUES. A REVIEW OF COMPLAINTS FOR FALSE POSITIVE TROPONIN RESULTS DID NOT IDENTIFY ANY ISSUES. FIELD SERVICE PERFORMED TROUBLESHOOTING THAT INCLUDED REPLACING THE PROBE (PART NUMBER 08C94-42) AND THE ORIGINAL VALVE, MANIFOLD KIT (PART NUMBER 7-77612-02) WHICH WAS REPLACED WITH THE IMPROVED VALVE, MANIFOLD KIT (PART NUMBER 7-77612-03). BASED ON THE INVESTIGATION THERE IS NO INDICATION OF A DEFICIENCY OF THE ARCHITECT I2000SR NOR IS THERE SUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ONE ARCHITECT ANALYZER IS GENERATING FALSELY ELEVATED TROPONIN RESULTS ON ONE PATIENT. RESULTS PROVIDED FROM (B)(6) 2014 ON SERIAL NUMBER (B)(4) = 0.025/ SECOND TUBE = 0.044 ON SN (B)(4). CUSTOMER'S NORMAL RANGE IS 0.0 - 0.026NG/ML. THE CUSTOMER REPEATED THE ASSAY ON SN (B)(4) AND RESULTS = 1ST TUBE 0.029; 2ND TUBE = 0.054NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290472 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT # 25470UN13| LOT # 25470UN13| ARCHITECT STAT TROPONIN-I, LIST # 02K41-27,| ARCHITECT STAT TROPONIN-I, LIST # 02K41-27,