BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 2120561 · Received June 10, 2011

    Report

    Report Number
    2954323-2011-03538
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 10, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE DID NOT INVOLVE A PRODUCT MALFUNCTION, NO FURTHER INVESTIGATION OF THE PRODUCT IS REQUIRED. THIS IS A FINAL REPORT. NOTE: THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HE HAS "INCORRECT TEST STRIP FOR HIS OMNIPOD METER" AND ON (B)(6) 2011 HE TESTED HIS BLOOD AT 2:30 AM, RECEIVED A READING OF 238 MG/DL AND AT 6:30 AM WOKE UP WITH PARAMEDICS SURROUNDING HIM. THE PARAMEDICS TREATED CUSTOMER WITH 50% DEXTROSE VIA INTRAVENOUS INFUSION AND TRANSPORTED TO A HOSPITAL WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND RECEIVED ADDITIONAL "GLUCOSE TREATMENT" TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE TEST STRIPS NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention