BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2130309 · Received June 16, 2011

    Report

    Report Number
    2954323-2011-03566
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 21, 2011
    Report Date
    August 3, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED, A DHR OF THE METER WAS REQUESTED. THE DEVICE HISTORY REVIEW FOR METER SN (B)(4) INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER'S FATHER REPORTED RECEIVING A HIGHER THAN FEELS READING OF 492 MG/DL ON THEIR FREESTYLE LITE METER AND MEDICATING HIS SON WITH INSULIN BASED ON THAT READING. THE CUSTOMER REPORTEDLY EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA AND SUBSEQUENTLY LOST CONSCIOUSNESS AND HAD A SEIZURE AS A RESULT OF OVERDOSING WITH INSULIN. THE PARAMEDICS WERE CALLED, ADMINISTERED GLUCOSE VIA INTRAVENOUS INFUSION AND TRANSPORTED CUSTOMER TO A HOSPITAL WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH PROTONIX (PANTOPRAZOLE) AND OTHER MEDICATIONS HE COULD NOT REMEMBER. THE CALLER MENTIONED "BOTH OF HIS SONS WERE HOSPITALIZED BECAUSE OF THIS ISSUE." ADC CUSTOMER SERVICE HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL 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| R