BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1984031 · Received February 10, 2011

    Report

    Report Number
    2954323-2011-01568
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 10, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THERE WAS NO PRODUCT COMPLAINT OR ISSUE REPORTED BY THE CUSTOMER, NO PRODUCT WILL BE RETURNED AND NO INVESTIGATION WILL BE PERFORMED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CALLED ADC CUSTOMER SERVICE TO RECEIVING TRAINING ON HOW TO CHANGE THE DATE IN THEIR FS FREEDOM LITE METER AND DURING THE CALL, THE CUSTOMER REPORTED AN INJURY. THE MEDICAL SURVEY WAS NOT COMPLETED AT THE TIME OF THE CALL AND SEVERAL UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO CLARIFY THE INJURY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other