BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1913121 · Received December 2, 2010

    Report

    Report Number
    1628664-2010-00455
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LGS
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO EVALUATE THE CUSTOMER ISSUE, A REVIEW WAS CONDUCTED OF THE COMPLAINT TEXT, THE INSTRUMENT HISTORY, AND ARCHITECT SYSTEM LABELING. A DEFINITE CAUSE OF THE ERRATIC TOXO IGG RESULT WAS NOT FOUND. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL ((B)(4)) AND THE ARCHITECT TOXO IGG REAGENT PACKAGE INSERT ((B)(4)) BOTH CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE AVAILABLE INFORMATION, A PRODUCT MALFUNCTION WAS NOT IDENTIFIED. AFTER REPROCESSING THE CONTROLS AND RECALIBRATING THE REAGENT, THE RESULTS WERE REPEATED WITHIN THE EXPECTED RANGES. REVIEW OF COMPLAINT TRACKING AND TRENDING; ABBOTT CUSTOMER TECHNICAL ADVOCATE INITIATED TROUBLESHOOTING WITH CUSTOMER INTERVENTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A FALSE POSITIVE RESULT HAS BEEN GENERATED ON ONE SAMPLE FROM A NON-IMMUNIZED PREGNANT FEMALE PATIENT TESTED WITH THE ARCHITECT TOXO IGG ASSAY. THE SAMPLE GENERATED AN INITIAL RESULT OF 13 IU/ML THAT RETESTED AT 0.1 / 0.1 IU/ML. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH TOXO IGG LN: 6C19 LOT 89736HN00| ARCH TOXO IGG LN: 6C19 LOT 89736HN00