BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROSET ANALYZER

    MDR report key: 974642 · Received January 8, 2008

    Report

    Report Number
    1628664-2008-00006
    Event Type
    Malfunction
    Date Received
    January 8, 2008
    Date of Event
    December 13, 2007
    Report Date
    December 13, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO INSPECT THE INSTRUMENT. THE CUVETTE WASHER HEAD WAS ADJUSTED, THE DRYER TIP WAS REPLACED, ALL WASHER NOZZLES WERE STYLETTED, AND THE ICT MODULE PROBE WAS ADJUSTED. THE SAMPLE ARM SHAFT A AND B TUBING, ICT JOINT TUBING, AND ICT VALVE TO FITTING TUBING WERE REPLACED AS A PRECAUTION. THE TEXT STATES PROPER ANALYZER OPERATION VERIFICATIONS WERE PERFORMED AND PASSED. THE CUSTOMER RAN CONTROLS FOR MULTIPLE ASSAYS, WITH ALL CONTROLS WITHIN ACCEPTABLE RANGE. THE ISSUE IS ADDRESSED IN THE CLINICAL CHEMISTRY (CC) GLUCOSE REAGENT AND PACKAGE INSERTS UNDER SECTIONS: REAGENT HANDLING AND STORAGE AND SPECIMEN COLLECTION AND HANDLING. THE AEROSET SYSTEM OPERATIONS MANUAL (P/N 200154-101 -- NOVEMBER 2004) ALSO ADDRESSES THIS ISSUE IN THE SECTION ENTITLED: SECTION 7, OPERATIONAL PRECAUTIONS AND LIMITATIONS - RESULTS INTERPRETATION AND REPORTING. A MALFUNCTION OF THE SYSTEM OCCURRED TO CAUSE THE GENERATION OF A DISCREPANT GLUCOSE RESULT. THE EXACT CAUSE OF THE MALFUNCTION COULD NOT BE DETERMINED AS MULTIPLE COMPONENTS WERE REPLACED IN TROUBLESHOOTING THE ISSUE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE RECEIVED BY MANUFACTURER CHANGED FROM (B)(4) 2004 TO (B)(4) 2007; TYPOGRAPHICAL ERROR. DEVICE MANUFACTURE DATE CHANGED FROM 01/2000 TO 11/01/2000; TYPOGRAPHICAL ERROR. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT MULTIPLE ASSAYS ARE GENERATING ABERRANT RESULTS ON THE AEROSET ANALYZER. ONE PT GENERATED AN INITIAL GLUCOSE ASSAY RESULT OF 33 MG/DL THAT RETESTED AT 129 AND 129 MG/DL. THERE IS NO IMPACT TO PT 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 UNK YR LIST # 7D66-20 OR 3L82-20, LOT # UNK| CLINICAL CHEMISTRY GLUCOSE ASSAY| CLIN CHEM GLUCOSE LN:7D66 OR 3L82 LOT:NI