BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1920036 · Received December 10, 2010

    Report

    Report Number
    1628664-2010-00473
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS CONCERNED WITH ASPIRATION AND WASH ZONE ERRORS WITH ERRATIC TROPONIN- I RESULTS BEING GENERATED ON THE ARCHITECT I2000SR ANALYZER. AN ABBOTT TECHNICAL APPLICATION SPECIALIST (TAS) REVIEWED THE MESSAGE HISTORY LOG AND FOUND MANY STAT PROBE OBSTRUCTION ERRORS AND WASH ZONE 2 ASPIRATION ERRORS. THE STAT PROBE HAD NOT BEEN REPLACED SINCE (B)(4) 2010. A REVIEW OF CUSTOMER MAINTENANCE LOGS REVEALED THAT THE LAST MAINTENANCE DOCUMENTATION WAS MADE IN (B)(4) 2010. THE TAS SUGGESTED THE CUSTOMER REPLACE THE STAT PROBE. ABBOTT FIELD SERVICE (FSR) WAS REQUESTED TO REPLACE THE PROBE, CHECK THE INSTRUMENT AND OPTIMIZE INSTRUMENT PERFORMANCE. THE FSR REPLACED THE PROBE TUBING ON PROBE #1 ON WASH ZONE 2. FURTHER INSTRUMENT EVALUATION FOUND THAT THE MOST LIKELY CAUSE OF THE CUSTOMER'S CURRENT ISSUE WAS A WEAK DRAIN VALVE ON WASH ZONE 2 VACUUM VESSEL WHICH CAUSED THE INSTRUMENT ERRORS. THE FSR REPLACED BOTH WASH ZONE 2 VACUUM VESSEL VALVES, AND THE WASH ZONE 2 PROBE TUBE SENSOR. LEAKING WASH ZONE MANIFOLDS WERE ALSO REPLACED. WASH ZONE ASPIRATION TESTS PASSED AND CONTROLS WERE WITHIN RANGE AND THE SYSTEM WAS PERFORMING WITHIN SPECIFICATIONS. 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 (PN 201837-108) JANUARY, 2010 AND THE ARCHITECT STAT TROPONIN-I PACKAGE INSERT ((B)(4)) BOTH CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE KNOWN TO BE NEGATIVE FOR TROPONIN-I, GENERATED ARCHITECT STAT TROPONIN-I ASSAY RESULTS IN THE RANGE OF 0.00 TO 0.16 UG/L (N=7) ON THE ARCHITECT I2000SR ANALYZER. THE CUSTOMER USES A TROPONIN-I CUTOFF VALUE OF 0.06 UG/ML. THE CUSTOMER DID NOT HAVE ANY FURTHER PATIENT INFORMATION. ABBOTT CONTROL MATERIALS HAVE BEEN WITHIN SPECIFICATIONS ON ALL RUNS. THE CUSTOMER NOTED THAT THE ANALYZER'S STAT PROBE HAD NOT BEEN REPLACED SINCE JULY 2010. ALSO THE MESSAGE HISTORY LOG OF THE ANALYZER SHOWED STAT PROBE OBSTRUCTION ERRORS. THE CUSTOMER USES LITHIUM HEPARIN IN THE COLLECTION TUBES AND DOUBLE CENTRIFUGES ALL SAMPLES. A SERVICE CALL WAS INITIATED. TO DATE, NO INFORMATION HAS BEEN PROVIDED CONCERNING PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH STAT TROPONIN-I LN: 2K41| ARCH STAT TROPONIN-I LN: 2K41