BEUDAMED
    FDA Adverse Event Other Summary report: N

    INPECO SYSTEM

    MDR report key: 930439 · Received October 22, 2007

    Report

    Report Number
    1628664-2007-00460
    Event Type
    Other
    Date Received
    October 22, 2007
    Date of Event
    September 20, 2007
    Report Date
    September 25, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT AFTER A NEW SPUR WAS INSTALLED ON THE C8000 SYSTEM, THE ACCOUNT OBSERVED THAT THE GATE ON THE SPUR WOULD SOMETIMES ALLOW 2 PUCKS WITH SAMPLE TUBES TO PASS THROUGH ON THE INPECO SYSTEM RESULTING IN VARIOUS SCENARIOS. ONE SCENARIO OBSERVED WAS THE IDENTIFICATION (ID) OF THE FIRST PUCK WOULD BE READ, BUT ANALYSIS OF THE PROCEEDING SAMPLE WOULD OCCUR INSTEAD, THEREBY GENERATING INCORRECT RESULTS FOR THE SAMPLE IN THE FIRST PUCK. OF 530 SAMPLES RUN, 31 SAMPLES HAD INCORRECT RESULTS GENERATED AND REPORTED. THE LABORATORY RERAN ALL SAMPLES, AND SENT OUT CORRECTED REPORTS. NO SPECIFIC PATIENT INFORMATION IS AVAILABLE FOR THE 31 SAMPLES. THE ACCOUNT ALSO INDICATED THAT AFTER INSTALLATION OF THE SPUR, THE SYSTEM DID NOT ALWAYS GENERATE SAMPLE PRESENTATION ERRORS AS EXPECTED. AS PER THE LAB'S POLICY, SAMPLES WITH THESE ERRORS WERE REPEATED. THE ACCOUNT STATED WHEN SAMPLES WITH THESE ERRORS WERE REQUESTED FOR REPEAT, THE SYSTEM DID NOT ALWAYS REPEAT ALL TESTS ORDERED, ONLY A FEW OF THE ORDERED TESTS. FIELD SERVICE (FS) WAS DISPATCHED TO INSPECT THE SYSTEM. THE FS REPRESENTATIVE ADJUSTED THE GATE TO THE C8000 ANALYZER, REMOVED 2M OF TUBING BETWEEN SV AND GATE MOVING THE SV CLOSER TO THE GATE, ADJUSTED ANTENNAE TO ENSURE NO ELECTRICAL INTERFERENCE, AND ALIGNED ANTENNAE AND GATE SO THAT THE PUCK ID COULD ONLY BE READ AT THE POINT WHERE ASPIRATION OCCURS. TO VERIFY THE PERFORMANCE OF THIS SPUR, THE CUSTOMER RAN 100 PREVIOUSLY RUN SAMPLES. ALL SAMPLES RECOVERED SIMILAR RESULTS AS COMPARED TO THE PREVIOUSLY GENERATED RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INPECO SYSTEM AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQW ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR C8000 ANALYZER