BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1612670 · Received February 23, 2010

    Report

    Report Number
    2954323-2010-00197
    Event Type
    Injury
    Date Received
    February 23, 2010
    Date of Event
    January 20, 2010
    Report Date
    February 22, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE METER IS RETURNED AND INVESTIGATION IS COMPLETE. TEST STRIPS (LOT # 0832301) WERE RETURNED ON 01-FEB-2010 FOR AN INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING USING A RETAINED LAB METER.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THE CUSTOMER RECEIVED A READING OF 86MG/DL ON THEIR BLOOD GLUCOSE METER. IT WAS ADDITIONALLY REPORTED THE CUSTOMER EXPERIENCED SYMPTOMS OF MIGRAINES, VOMITING, AND PASSED OUT. THE CUSTOMER WAS REPORTEDLY SEEN BY A DOCTOR, BUT NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER REPORTEDLY DRANK LIQUIDS AND ATE FOOD TO ALLEVIATE THEIR SYMPTOMS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM NBW 0832301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other