BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1963036 · Received January 18, 2011

    Report

    Report Number
    2954323-2011-00704
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 23, 2010
    Report Date
    July 14, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER ON FOLLOW-UP #1 SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2011. AS PER THE ARRANGEMENTS DISCUSSED WITH (B)(4) AT FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(4) 2011 LETTER ADDRESSED TO (B)(6).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THE CUSTOMER RECEIVED WITH 10 MINUTES THE FOLLOWING READING ON THEIR FREESTYLE LITE BLOOD GLUCOSE METER: 478 MG/DL (6:20 AM), 112 MG/DL (6:20 AM), 93 MG/DL (6:21 AM) AND 60 MG/DL (6:22 AM). THE CUSTOMER REPORTEDLY ATE BETWEEN READINGS, AND THE CUSTOMER'S MOTHER ALSO REPORTED SHE DID NOT TREAT THE CUSTOMER WITH THEIR INSULIN. IT WAS REPORTED THE CUSTOMER EXPERIENCED A MEDICAL EVENT WHEN THEY LOST CONSCIOUSNESS AROUND 6:27 AM. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED AND NO MEDICATIONS WERE REPORTEDLY TAKEN TO COUNTERACT THE EVENT. THE CUSTOMER REPORTEDLY ATE PANCAKE SYRUP AND DRANK FRUIT 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1020328

    Patients

    Seq Age Sex Outcome Treatment
    1 Other