BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2771051 · Received October 3, 2012

    Report

    Report Number
    1628664-2012-00445
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED BY REPLACING THE VALVES ON THE WASH ZONE MANIFOLD AND TRIGGER/PRE-TRIGGER MANIFOLD. THE VALVE IS A COMMONLY REPLACED PART TO ADDRESS FLUIDICS ISSUES. THE MANIFOLD VALVE IS TO BE INSPECTED AND REPLACED IF NECESSARY ACCORDING TO PREVENTATIVE MAINTENANCE PROCEDURES. CURRENT LABELING PROVIDES TROUBLESHOOTING ASSISTANCE FOR ERRATIC RESULTS. THE ARCHITECT SYSTEM OPERATIONS MANUAL LISTS PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC RESULTS. "WASH BUFFER DISPENSE AT THE WASH ZONES IS INADEQUATE" AND "PRE-TRIGGER OR TRIGGER DISPENSE IS INADEQUATE" ARE LISTED AS PROBABLE CAUSES. THE OPERATIONS MANUAL INSTRUCTS THE OPERATOR TO PERFORM DIAGNOSTIC PROCEDURES TO CHECK THE WASH ZONES AS A CORRECTIVE ACTION. THE CUSTOMER IS THEN DIRECTED TO CONTACT AREA CUSTOMER SUPPORT IF INSUFFICIENT VOLUME IS DISPENSED. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY OF THE SYSTEM WAS NOT IDENTIFIED. INADEQUATE DISPENSE OF SOLUTIONS IS RECOGNIZED AS A PROBABLE CAUSE OF ERRATIC RESULTS. A MALFUNCTION OF THE MANIFOLD VALVES WAS IDENTIFIED WHICH WAS RESOLVED BY REPLACING THE VALVES. REVIEW OF SERVICE TICKET HISTORY DID NOT IDENTIFY ANY OTHER ISSUES THAT MAY HAVE CONTRIBUTED TO THE CURRENT COMPLAINT. NO FURTHER ACTION IS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROGRESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED FALSE REACTIVE ARCHITECT STAT TROPONIN-I RESULTS (0.2, 0.081, 0.031, 0.062 NG/ML) ON A PATIENT SERUM SAMPLE THAT REPEATED NEGATIVE (0.015, 0.016, 0.014 NG/ML) USING THE ARCHITECT I2000SR. THE SAMPLE WAS REPEATED ON THE ARCHITECT I1000SR WITH NEGATIVE TROPONIN RESULTS (0.000, 0.004, 0.005, 0.000 NG/ML). THE ACCOUNT USES A CUTOFF OF 0.028 NG/ML FOR TROPONIN. NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.

    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 STAT TROPONIN-I, LIST 02K41-28| LOT 79248UN12| ARCHITECT STAT TROPONIN-I, LIST # 2K41-01| LOT # 79248UN12