BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 866163 · Received April 18, 2007

    Report

    Report Number
    1628664-2007-00106
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Date of Event
    February 21, 2007
    Report Date
    March 19, 2007
    Manufacturer
    ABBOTT LABORATORIES, INC
    Product Code
    JJE
    PMA / PMN Number
    k983212
    Removal / Correction Number
    1628664-04112007-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    MICROBIAL CONTAMINATION WITHIN THE ARCHITECT SYSTEM (ARCHITECT I2000/I2000 SR PROCESSING MODULES AND ARCHITECT WASH BUFFER) THROUGH GENERATION OF FOLATE-LIKE BY-PRODUCTS (MICROBIAL FOLATE) MAY CAUSE ARCHITECT FOLATE CALIBRATION FAILURES AND SHIFTS IN ARCHITECT FOLATE RESULTS (QC AND PT RESULTS).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO