BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1932992 · Received December 20, 2010

    Report

    Report Number
    1628664-2010-00491
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. NO ERROR CODES WERE GENERATED WHEN THE FALSE (B)(6) HCV RESULT WAS GENERATED. TRACKING AND TRENDING DID NOT IDENTIFY ANY ADVERSE TREND IN CONJUNCTION WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT (B)(4) ANALYZER GENERATED A (B)(6) RESULT FOR ONE PATIENT SAMPLE KNOWN TO BE A CARRIER OF (B)(6). THE ARCHITECT ANALYZER GENERATED AN INITIAL (B)(6) RESULT OF 0.03 S/CO AND A REPEAT RESULT OF 13.39 S/CO. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ANTI-HCV REAGENT LN 6C37-20 LOT 88508HN00| ANTI-HCV REAGENT LN 6C37-20 LOT 88508HN00