BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1883258 · Received October 26, 2010

    Report

    Report Number
    2954323-2010-01483
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 26, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER (SERIAL # (B)(4)) AND TEST STRIPS (LOT # 1001519) WERE RETURNED FOR AN INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. THE READING OF 251 MG/DL AND 50 MG/DL WERE NOT FOUND IN THE METER MEMORY LOG ON THE DATE OF (B)(6), 2010. HOWEVER, THE READINGS OF 247 MG/DL (2:10 PM) AND 54 MG/DL (2:21 PM) WERE FOUND ON THE SAME DATE AND THEY WERE NOT COMPLETED WITHIN TEN MINUTES. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER'S FAMILY MEMBER REPORTED THAT ON (B)(6), 2010 (12:30 PM) THE CUSTOMER RECEIVED A READING OF 251 MG/DL, LOST CONSCIOUSNESS "AFTER A FEW MINUTES", AND THEN A READING OF 50 MG/DL WAS OBTAINED. DURING THE MEDICAL EVENT, IT WAS ALSO REPORTED THE CUSTOMER EXPERIENCED DIZZINESS, BLURRED VISION AND HAD A LITTLE BUMP ON THEIR HEAD. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER REPORTEDLY DRANK ORANGE JUICE 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 BLOOD GLUCOSE MONITORING SYSTEM NBW 1001519

    Patients

    Seq Age Sex Outcome Treatment
    1 Other