BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEROSET ANALYZER

    MDR report key: 889947 · Received August 7, 2007

    Report

    Report Number
    1628664-2007-00384
    Event Type
    Other
    Date Received
    August 7, 2007
    Date of Event
    July 10, 2007
    Report Date
    July 13, 2007
    Manufacturer
    ABBOTT MANUFACTURING INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT TECHNICAL EXECUTIVE ARRIVED ON SITE AND REPLACED THE ACID WASH VALVE AFTER OBSERVING A DRIED SALT BUILD-UP AROUND THE VALVE. PREVENTIVE MAINTENANCE WAS ALSO PERFORMED AND NO ISSUES WERE FOUND WITH THE ASSAY FILE. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THIS ISSUE IS ADDRESSED IN THE AEROSET SYSTEM OPERATIONS MANUAL (LIST#: 9D06-05, 200155-101, NOVEMBER 2004), SECTION 10. TROUBLESHOOTING AND DIAGNOSTICS, RESULTS ARE ERRATIC; PRECISION IS POOR. THE INVESTIGATION DEMONSTRATED THAT THE AEROSET ANALYZER IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PHYSICIAN QUESTIONED THE RESULT OF THE ONE HOUR TIME POINT FROM A GLUCOSE TOLERANCE TEST ON A PREGNANT FEMALE PATIENT PERFORMED ON THE AEROSET ANALYZER. THE INITIAL RESULT OF 382 MG/DL RE-TESTED AT 181 MG/DL. THE RETESTED SAMPLE HAD BEEN STORED FOR TWO DAYS IN THE LAB REFRIGERATOR. CONTROLS HAVE BEEN WITHIN SPECIFICATIONS. THE CUSTOMER FEELS THAT THE SAMPLE FROM THE QUESTIONED RESULT MAY HAVE CONTAINED A CLOT AND CAUSED THE ERRATIC RESULT. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED. A SERVICE CALL WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROSET ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR LIST# 3L82-40 LOT# 45074HW00| CLINICAL CHEMISTRY GLUCOSE REAGENT