BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1984107 · Received February 10, 2011

    Report

    Report Number
    2954323-2011-01537
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    December 29, 2010
    Report Date
    February 7, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A FINAL REPORT. NO PRODUCT PROBLEM WAS REPORTED. COMPLAINT INVOLVED A DELIVERY DELAY, NO FURTHER INVESTIGATION WILL BE UNDERTAKEN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2010 DUE TO NOT RECEIVING A LANCING DEVICE TO USE WITH HER FREESTYLE LITE BLOOD GLUCOSE METER, WHICH WAS ORDERED ON NOVEMBER 29, 2010, SHE "GOT SICK AND HAD TO GO TO THE HOSPITAL". IT WAS FURTHER REPORTED CUSTOMER SUBSEQUENTLY EXPERIENCED A LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED, "MONITORED" HER STATUS, ADMINISTERED AN UNKNOWN AMOUNT OF INSULIN AND TRANSPORTED CUSTOMER TO A LOCAL HEALTHCARE FACILITY. CUSTOMER DID NOT KNOW IF SHE RECEIVED ANY DIABETES RELATED DIAGNOSIS AND COULD NOT RECALL WHAT TREATMENT WAS PROVIDED. HOWEVER, SHE DID REPORT A DIAGNOSIS OF "MIGRAINES". ADDITIONALLY, CUSTOMER REPORTED SELF-TREATING WITH "UNKNOWN" PRESCRIPTION MEDICATIONS AS WELL AS "FOOD AND DRINK". THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other