BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1907852 · Received November 24, 2010

    Report

    Report Number
    2954323-2010-01607
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 5, 2010
    Report Date
    July 15, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS CUSTOMER'S TEST STRIPS WERE NOT RETURNED A DEVICE HISTORY REVIEW OF THE STRIPS WERE REQUESTED AND PERFORMED. THE DEVICE HISTORY REVIEW FOR TEST STRIP (B)(4) INDICATED THE STRIPS WERE PERFORMING WITHIN THEIR PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO THEIR RELEASE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER ON FOLLOW-UP #1 SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2011. AS PER THE ARRANGEMENTS DISCUSSED WITH THE OFFICE OF SURVEILLANCE AND BIOMETRICS AT FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(6) 2011 LETTER ADDRESSED TO SHARON KAPSCH, MDR CHIEF POLICY BRANCH AT OSB.

    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: -REPORTED TEST STRIP LOT # 0811718 IS EXPIRED (EXPIRATION: APRIL/2010).

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER REPORTED THAT BACK IN (B)(6) OF 2010 (DAY AND TIME ARE UNKNOWN) THE CUSTOMER RECEIVED AN UNKNOWN HIGH READING ON HIS FREESTYLE FREEDOM BLOOD GLUCOSE METER. THE CUSTOMER'S DAUGHTER ALSO REPORTED THE CUSTOMER EXPERIENCED AN INJURY AND "WENT INTO A DIABETIC SHOCK". THE PARAMEDICS WERE CALLED, BUT THE CUSTOMER'S TREATMENT IS REPORTEDLY UNKNOWN. THE CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY AND THERE IS NO FURTHER INFORMATION ABOUT THE EVENT AS THE CUSTOMER'S DAUGHTER REFUSED TO COMPLETE THE TROUBLESHOOTING SURVEY QUESTIONS. HOWEVER BEFORE THE CALL WITH ADC CUSTOMER SERVICE ENDED, IT WAS ADDITIONALLY REPORTED THE CUSTOMER RECEIVED A READING OF 118 MG/DL ON (B)(6), 2010 AT 9 AM AND, ACCORDING TO THE CUSTOMER'S DAUGHTER, THE READING WAS HIGHER THAN THE CUSTOMER FELT. THERE WAS NO REPORT OF THIRD-PARTY MEDICAL INTERVENTION AND NO ADVERSE EVENT RELATED TO THE READING OF 118 MG/DL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 0811718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other