BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2073396 · Received May 1, 2011

    Report

    Report Number
    2954323-2011-03105
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    April 22, 2011
    Report Date
    June 24, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED, A DHR OF EACH METER REPORTED WAS REQUESTED. THE DEVICE HISTORY REVIEW FOR METERS (B)(4) INDICATED THE DEVICES WERE PERFORMING WITHIN PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO RELEASE. 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. NOTE: THE DEVICE MANUFACTURING DATE IS FROM THE METER SERIAL # (B)(4); THE DEVICE MANUFACTURING DATE OF METER (B)(4) IS (B)(6) 2008. THE DATE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    ADC CUSTOMER SERVICE RECEIVED A CORRESPONDENCE FROM A CUSTOMER WHO REPORTED HIS SON WAS HOSPITALIZED DUE TO A HYPOGLYCEMIC SEIZURE. ON A LATER CONTACT, THE CUSTOMER COULD REPORTEDLY CLARIFY THAT HE BELIEVED THAT BOTH FREESTYLE LITE BLOOD GLUCOSE METERS (SERIAL # (B)(4) AND (B)(4)) WERE READING INCORRECTLY, BUT HE DID NOT HAVE TIME TO COMPLETE THE ADC TROUBLESHOOTING SURVEYS. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY 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 Hospitalization