BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 1962133 · Received January 17, 2011

    Report

    Report Number
    1628664-2011-00047
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF DOCUMENTATION IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. A DEFICIENCY WAS IDENTIFIED; POSSIBLY DUE TO SAMPLE OR REAGENT CARRY-OVER. FURTHER INVESTIGATION OF THIS QUALITY ISSUE WILL BE CONDUCTED. A FINAL 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 I1000SR ANALYZER GENERATED A FALSE POSITIVE B-HCG RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT GENERATED AN INITIAL B-HCG RESULT OF 67.03 MIU/ML, AND REPEAT B-HCG RESULTS OF 7.94 MIU/ML AND <1.20 MIU/ML. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARCH I1000SR LN 01L86-01 SN (B)(6)