BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 1905057 · Received November 22, 2010

    Report

    Report Number
    1628664-2010-00431
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO INVESTIGATE THE CUSTOMER ISSUE, THE COMPLAINT TEXT, THE INSTRUMENT HISTORY, AND ARCHITECT SYSTEM LABELING WERE REVIEWED. AFTER FIELD SERVICE REPLACED THE SYRINGE VALVES, PIPETTOR PROBE, WASH ZONE VALVES, AND THE WASH ZONE NEEDLES, THE INSTRUMENT RETURNED TO RUNNING WITHIN SPECIFICATIONS. NO ADDITIONAL OCCURRENCES OF (B)(6) RESULTS HAVE BEEN OBSERVED. THE REVIEW SHOWED THE ARCHITECT SYSTEM OPERATIONS MANUAL DOES ADDRESS OPERATIONAL PRECAUTIONS, LIMITATIONS, AND ERRATIC RESULTS INCLUDING PROBABLE CAUSES AND CORRECTIVE ACTIONS. IN THE ARCHITECT (B)(6) REAGENT PACKAGE INSERT (B)(6), LITERATURE IS PROVIDED IN DESCRIBING SUITABLE SPECIMENS, RESULTS, AND LIMITATIONS OF THE PROCEDURE. A COMPLETE INSPECTION OF THE INSTRUMENT WAS PERFORMED BY FIELD SERVICE. FIELD SERVICE OBSERVED SPLASHING AT THE PROBE. HE PROCEEDED TO REPLACE THE SYRINGE VALVES, PIPETTOR PROBE, WASH ZONE VALVES, AND THE WASH ZONE NEEDLES. THE PIPETTOR CALIBRATION AND WASH ZONE ASPIRATION TESTS PASSED. THE FIELD SERVICE REPRESENTATIVE STATED THE PROBABLE CAUSE OF THE COMPLAINT ISSUE WAS THE SPLASHING THAT OCCURRED AT THE PIPETTOR PROBE LOCATION WHICH CAUSED INTERMITTENT CONTAMINATION. THE QUALITY CONTROL VALUES WERE WITHIN ACCEPTABLE RANGES. NO ADVERSE TREND WAS IDENTIFIED RELATED TO THIS ISSUE WAS IDENTIFIED. THE CUSTOMER ISSUE IS ADEQUATELY ADDRESSED IN PRODUCT LABELING. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS DETERMINED.

    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 WHEN PROCESSING A PATIENT SAMPLE USING THE ARCHITECT HIV AG/AB COMBO ASSAY A POTENTIAL FALSELY (B)(6) WAS GENERATED IN COMPARISON WITH A (B)(6) OBTAINED UPON RETEST OF THE SAME SAMPLE. NO ADVERSE OUTCOMES WERE REPORTED RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC HIV AG/AB RGT LN 4J27-20 LOT # 90321HN00| ARC HIV AG/AB RGT LN 4J27-20 LOT # 90321HN00