BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2885199 · Received December 26, 2012

    Report

    Report Number
    1628664-2012-00513
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    OMI
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A (B)(6) RESULT FOR ONE PATIENT SAMPLE. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. REVIEW OF THE MESSAGE HISTORY FOUND MULTIPLE LIQUID NOT FOUND AND ASPIRATION ERRORS FOR THE SAMPLE PIPETTOR. REPLACEMENT OF THE PROBE RESOLVED THE ISSUE. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TRENDS OR NON-STATISTICAL TRENDS FOR THE PROBE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A (B)(6) RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT GENERATED A RESULT (B)(6). THE SAMPLE WAS RETESTED ON A VIDAS ANALYZER AND A NEGATIVE (B)(6) RESULT WAS GENERATED. THE (B)(6) RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER OMI ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH CMV IGM LN 06C16-25 LOT 20561LF00| ARCH CMV IGM LN 06C16-25 LOT 20561LF00