BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1993972 · Received February 16, 2011

    Report

    Report Number
    2954323-2011-01650
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 22, 2011
    Report Date
    February 16, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR METER OF 130MG/DL AND 79MG/DL OBTAINED WITHIN TEN MINUTES OF ONE ANOTHER. THE CUSTOMER FURTHER REPORTED THAT AT THE TIME OF THE READINGS ISSUE, SHE EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA AND SUBSEQUENTLY LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND OBTAINED AN HCP METER READING OF 35MG/DL AND TREATED CUSTOMER ON SCENE WITH INTRAVENOUS FLUIDS AND TWO DOSES OF DEXTROSE. CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY AND NO DIAGNOSIS WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1079212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other