BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1973101 · Received January 28, 2011

    Report

    Report Number
    2954323-2011-01255
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 29, 2010
    Report Date
    February 25, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCTS WERE RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND 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 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 FELT HIS BLOOD GLUCOSE LEVEL WAS "LOW" AND WHEN HE TESTED HIS BLOOD GLUCOSE HE OBTAINED A READING OF 234 MG/DL ON HIS FREESTYLE LITE BLOOD GLUCOSE METER. THE CUSTOMER REPORTEDLY LOST CONSCIOUSNESS AND THEN WHEN HE TESTED HIS BLOOD GLUCOSE AGAIN HE OBTAINED A READING OF 215 MG/DL. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED AND NO MEDICATIONS WERE REPORTEDLY TAKEN TO COUNTERACT THE EVENT. THE CUSTOMER'S MOTHER REPORTED THE CUSTOMER ATE FOOD AND DRANK A SOFT DRINK TO ALLEVIATE HIS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other