BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 3473419 · Received November 18, 2013

    Report

    Report Number
    2954323-2013-00593
    Event Type
    Injury
    Date Received
    November 18, 2013
    Date of Event
    October 17, 2013
    Report Date
    October 17, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. IT IS UNKNOWN WHEN THE MEDICAL EVENT ACTUALLY OCCURRED. THE EVENT DATE LISTED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED AND TEST STRIP LOT REPORTED WITH THIS COMPLAINT IS EXPIRED, A DEVICE HISTORY REVIEW (DHR) OF THE METER WAS REQUESTED. THE DHR FOR METER SERIAL NUMBER (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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING THE FOLLOWING READINGS FROM HIS ADC BLOOD GLUCOSE METER, WHICH HE PERCEIVED TO BE ERRATIC: 133 MG/DL AT 4:17 AM ON (B)(6) 2013, 108 MG/DL AT 4:15 AM ON (B)(6) 2013 AND 102 MG/DL AT 3:18AM ON (B)(6) 2013. CUSTOMER ADDITIONALLY REPORTED HE SELF-ADMINISTERED A GLUCAGON INJECTION. IT IS UNKNOWN WHEN THE GLUCAGON WAS TAKEN RELATIVE TO WHEN THE REPORTED READINGS WERE RECEIVED, AS THIS INFORMATION WAS NOT OBTAINED AT THE TIME OF THE CUSTOMER'S CALL. MULTIPLE, UNSUCCESSFUL, ATTEMPTS TO CONTACT THIS CUSTOMER HAVE BEEN MADE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595510 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1265054

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention