BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1040091 · Received May 7, 2008

    Report

    Report Number
    2954323-2008-01731
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 7, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED HIS METER. THE REPORTED READINGS ON THE DATE OF THE EVENT WERE NOT FOUND IN THE METER MEMORY LOG. DEVICE EVAL ON THE RETURNED METER DID NOT CONFIRM THE PRECISION READING COMPLAINT AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN SPECIFICATION AND NO ERRORS WERE OBSERVED DURING THE CONTROL SOLUTION TESTING. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A READING OF 179 MG/DL ON HIS FREESTYLE FLASH BLOOD GLUCOSE METER AND TAKING 15 UNITS OF INSULIN BASED ON THE READING RECEIVED. THE CUSTOMER ALSO REPORTED SWEATING PROFUSELY, FEELING HIS SUGAR WAS VERY LOW AND LOSING CONSCIOUSNESS. THE PARAMEDICS WERE CALLED AND TREATED HIM WITH AN UNK INTRAVENOUS SOLUTION. THERE WAS NO MEDICAL DIAGNOSIS OF SEVERE HYPO-OR HYPERGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT. ADDITIONALLY, THE CUSTOMER REPORTED RECEIVING READINGS WITHIN TEN MINUTES. RESULTS OF 90 MG/DL AND 179 MG/DL WERE PLOTTED AGAINST THE AVERAGE ON A PARKES ERROR GRID. THE RESULTS FELL INTO THE "B" ZONE SHOWING THE DIFFERENCE IN VALUES WAS NOT CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NA 0736223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention