BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2222685 · Received August 25, 2011

    Report

    Report Number
    1628664-2011-00588
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. NO SINGLE DEFINITIVE CAUSE WAS DETERMINED. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ARCHITECT TOXO IGG REAGENT PACKAGE INSERT WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE OF FALSELY ELEVATED RESULTS. AFTER THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED INSTRUMENT TROUBLESHOOTING AND REPLACED THE WASH ZONE 1 NEEDLE IN WASH ZONE 2, THE INSTRUMENT PERFORMED WITHIN SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION A DEFICIENCY OF THE ARCHITECT SYSTEM WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. FALSE POSITIVE RESULT (B)(4); NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSE REACTIVE TOXO IGG RESULT FOR TWO PATIENT SPECIMENS. PATIENT 1: THE ARCHITECT GENERATED AN INITIAL TOXO IGG RESULT OF 29 (NO UNITS OF MEASUREMENT PROVIDED) AND A NEGATIVE RESULT OF <1.6 (NO UNITS OF MEASUREMENT WAS PROVIDED ) WHEN REPEATED. PATIENT 1 WAS PREVIOUSLY KNOWN TO BE TOXO IGG NEGATIVE. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT TOXO IGG, LIST 6C19-25| ARCHITECT TOXO IGG 6C19-25