BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 2221067 · Received August 23, 2011

    Report

    Report Number
    2954323-2011-04286
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 11, 2011
    Report Date
    October 20, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. 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. IT SHOULD BE NOTED: THE TREATMENT PROVIDED (INTRAVENOUS GLUCOSE) IS INCONSISTENT WITH THE DIAGNOSIS.

    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 (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 THAT HER ADC BLOOD GLUCOSE METER TURNS ON AND OFF AFTER STRIP INSERTION. IN ADDITION, CUSTOMER ALSO REPORTED AN UNSPECIFIED READINGS ISSUE ON HER METER. CUSTOMER FURTHER REPORTED SUBSEQUENTLY EXPERIENCING NIGHT SWEATS (SWEATING PROFUSELY), "ALMOST HAD A DIABETIC COMA", AND LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND RESPONDED. CUSTOMER WAS GIVEN GLUCOSE INTRAVENOUSLY. CUSTOMER WAS TRANSPORTED TO A HEALTH CARE FACILITY. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS AND RECEIVED ADDITIONAL UNSPECIFIED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 0836304

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R