BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 3955191 · Received July 24, 2014

    Report

    Report Number
    2954323-2014-00807
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IS THE DATE 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 NO TEST STRIP LOT WAS REPORTED WITH THIS COMPLAINT, 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 UNSPECIFIED READINGS ON HIS ADC BLOOD GLUCOSE METER, WHICH HE PERCEIVED TO BE ERRATIC. CUSTOMER FURTHER REPORTED HE SELF-INJECTED GLUCAGON AS A RESULT OF THE READINGS RECEIVED, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER AND ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434904 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention