BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROSET ANALYZER

    MDR report key: 1211964 · Received October 28, 2008

    Report

    Report Number
    1628664-2008-00245
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ERRATIC RESULT ISSUE WAS RESOLVED BY THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACING AND CALIBRATING THE REAGENT PROBES. POTASSIUM CONTROL RESULTS WERE VERIFIED TO BE AT TARGET VALUES AFTER THE REAGENT PROBES WERE REPLACED. THE COMPLAINT TEXT ALSO NOTES THE CUSTOMER SITE HAD IMPURITIES IN THE WATER SUPPLY PIPE. LABELING REVIEW: THE AEROSET OPERATIONS MANUAL LIST NO. 09D06-05 WAS REVIEWED AND WAS FOUND TO CONTAIN ADEQUATE INFORMATION ON PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC RESULTS. SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS LISTS MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR ERRATIC RESULTS OR PRECISION IS POOR. THESE PROBABLE CAUSES INCLUDE LEAKING, DRIPPING, DAMAGED OR OBSTRUCTED REAGENT PROBES, AND DIRTY WATER BATH. CORRECTIVE ACTIONS INCLUDE REPLACING THE REAGENT PROBES AND CHANGING THE WATER IN THE BATH. SERVICE HISTORY REVIEW: A REVIEW OF COMPLAINTS FOR THE TIME PERIOD OF (B)(6) 2008 TO (B)(6) 2008 FOUND NO ADDITIONAL INCIDENTS OF AEROSET SERIAL NUMBER (B)(4) GENERATING ERRATIC RESULTS SINCE THE REAGENT PROBES WERE REPLACED BY THE FSR ON (B)(6) 2008. A REVIEW OF US AND INTERNATIONAL COMPLAINTS FOR ERRATIC, INCONSISTENT AND ABERRANT RESULTS FROM (B)(6) 2007 THROUGH (B)(6) 2008 DETERMINED THE RATES ARE CURRENTLY WITHIN ESTABLISHED LIMITS. NO PRODUCT DEFICIENCY WAS IDENTIFIED. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED A PATIENT GENERATED A POTASSIUM RESULT OF 9.7 MMOL/L ON THE AEROSET ANALYZER. THE SAMPLE WAS RETESTED YIELDING A POTASSIUM RESULT OF 4.1 MMOL/L. THE VALUE OF 4.1 MMOL/L ALIGNED WITH THE PATIENT'S PREVIOUS VALUE AND WAS CONFIRMED CORRECT ON ANOTHER AEROSET ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1