BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1139397 · Received August 28, 2008

    Report

    Report Number
    2954323-2008-02470
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    July 19, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER'S MOTHER REPORTED HER SON HAD BEEN EXPERIENCING VOMITING, DEHYDRATION, HEADACHE, DIZZINESS, WEIGHT LOSS, DISCOLORATION OF THE SKIN AND STOMACH PAIN WHEN HE GOT HOSPITALIZED, DIAGNOSED WITH SEVERE HYPERGLYCEMIA AND TREATED WITH INSULIN INJECTIONS. THEY ALSO REPORTED RECEIVING READINGS OF 76, 102, 123, AND 62 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO A "B" ZONE SHOWING DIFFERENCE IN VALUES TO BE CLINICALLY INSIGNIFICANT. ALTHOUGH THE CALLER REPORTED THESE READINGS IN 2008, IT IS STILL UNCLEAR WHETHER THESE READINGS ON THE SAME DAY, IT IS STILL UNCLEAR WHETHER THESE READINGS WERE OBTAINED AT THE TIME OF THE MEDICAL EVENT, WHICH OCCURRED ON THE SAME DAY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NI 0804301

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization