BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 2212206 · Received August 15, 2011

    Report

    Report Number
    2954323-2011-04204
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 15, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. COMPLAINT INVOLVED A DELIVERY ISSUE, HENCE NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE DATE OF MANUFACTURE IS UNKNOWN. THE DATE LISTED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 1

    A FRIEND OF A CUSTOMER REPORTED A DELIVERY ISSUE INVOLVING A FREESTYLE FLASH BLOOD GLUCOSE METER FROM THE FREESTYLE PROMISE PROGRAM. CALLER FURTHER REPORTED THAT ON (B)(6) 2011 CUSTOMER EXPERIENCED CRAMPS IN HER FOOT CAUSING HER TO FALL. CALLER INDICATED CUSTOMER'S SUGAR WAS "VERY HIGH" (UNKNOWN RESULT) AND NOTED CUSTOMER WAS GIVEN 50 UNITS OF HUMULIN N INSULIN BY THE CALLER AND THEN RECEIVED AN ADDITIONAL 20 UNITS "LATER". CALLER REPORTED CUSTOMER EXPERIENCED SEVERE PAIN AND LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND TRANSPORTED CUSTOMER TO A LOCAL HEALTHCARE FACILITY, WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA. AT THE HOSPITAL CUSTOMER HAD HER BLOOD GLUCOSE MONITORED AND WAS GIVEN A SHOT OF TORADOL (KETOROLAC TROMETHAMINE) AND A SHOT OF DILAUDID (HYDROMORPHONE). CUSTOMER ADDITIONALLY SELF-TREATED WITH LORTAB (ACETAMINOPHEN AND HYDROCODONE) AND TYLENOL. 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 FLASH BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R