BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1077143 · Received July 15, 2008

    Report

    Report Number
    1628664-2008-00172
    Event Type
    Malfunction
    Date Received
    July 15, 2008
    Date of Event
    April 7, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    DHA
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE REP (FSR) HAD BEEN DISPATCHED TO THE CUSTOMER SITE SEVERAL TIMES AND REPLACED MULTIPLE COMPONENTS IN AN ATTEMPT TO RESOLVE THE CUSTOMER'S ISSUE. THE LATEST VISIT HAD THE FSR PERFORMING THE FOLLOWING ON THE ANALYZER: CHECKED THE R1 AND R2 (REAGENT) WASH STATION DISPENSERS AND FOUND DIFFERENT VOLUMES OF BUFFER BEING DISPENSED. FURTHER INVESTIGATION FOUND THAT THE CONNECTORS FOR THE R1 AND R2 VALVES WERE SWITCHED SO THE FSR CORRECTED THE ISSUE BY THE CORRECT PLACEMENT OF THE CONNECTORS. THE FSR THEN SUCCESSFULLY PERFORMED FUNCTIONAL TESTING RECOVERING THE CORRECT VOLUMES. THE FSR THEN RAN POSITIVE AND NEGATIVE PT SAMPLE IN REPLICATES GETTING ACCEPTABLE RESULTS. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE ARCHITECT SYSTEM OPERATIONS MANUAL (PN 201837-104) 2007 IN SECTION 7, OPERATIONAL PRECAUTIONS AND LIMITATIONS AND SECTION 10 - TROUBLESHOOTING AND DIAGNOSIS, OBSERVED PROBLEMS. THE EXACT CAUSE OF THE CUSTOMER'S OBSERVATION OF FALSE POSITIVE BHCG SAMPLES WAS NOT DETERMINED. THE FSR REPLACED MULTIPLE COMPONENTS IN AN EFFORT TO TROUBLESHOOT THE ISSUE FINALLY RETURNING THE INSTRUMENT TO WITHIN THE CORRECT SPECIFICATION. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PT'S ARCHITECT I2000 TOTAL BHCG ASSAY RESULT OF 3000 MIU/ML WAS QUESTIONED BY A PHYSICIAN. THE SAME SAMPLE WAS THEN RETESTED AND GENERATED A RESULT OF <1.2 MIU/ML. AN ABBOTT FIELD SERVICE REP (FSR) SENT TO THE CUSTOMER SITE COULD NOT REPRODUCE THE ISSUE, EVEN AFTER RUNNING FOUR ELEVATED (POSITIVE) BHCG SAMPLES PRIOR TO THE SAMPLE IN QUESTION. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER DHA ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ARCHITECT B-HCG ASSAY LIST#: 7K78-20| LOT#: 55936JN00