BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 4244011 · Received November 11, 2014

    Report

    Report Number
    1628664-2014-00233
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE (ARCHITECT I2000 ANALYZER, CATALOG # 08C89-01) IS NO LONGER CONSIDERED THE CAUSE OF THE INCIDENT REPORTED. THIS INFORMATION WAS ADDED TO THE COMPLAINT TICKET ON NOVEMBER 12, 2014. THEREFORE, NO FURTHER FOLLOW-UP IS REQUIRED FOR THIS MEDICAL DEVICE RELATED TO THIS INCIDENT. THIS MEDICAL DEVICE IS NO LONGER SUSPECT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT FALSE REACTIVE ARCHITECT HCV AG RESULTS WERE GENERATED FOR TWO PATIENTS. INITIAL RESULTS WERE REACTIVE AND RETEST RESULTS WERE NONREACTIVE. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. PATIENT 1 ((B)(6) 2014): INITIAL RESULT (ID 700109) 126.39 FMOL/L AND RETEST RESULT (ID (B)(6)) 0.27 FMOL/L PATIENT 2 ((B)(6)2014): INITIAL RESULT (ID 000319) 118.56 FMOL/L AND RETEST RESULT (ID (B)(6)) 0.00 FMOL/L

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725737 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LIST 08C89-01, SERIAL (B)(4)| ARCHITECT I2000 ANALYZER