BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1900723 · Received November 16, 2010

    Report

    Report Number
    2954323-2010-01563
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 28, 2010
    Report Date
    December 29, 2010
    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 INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED METER (B)(4) AND STRIP LOT NUMBER 0931816. THE COMPLAINT WAS NOT CONFIRMED AND ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. IN ADDITION, THE READING REPORTED WAS FOUND IN THE INTERNAL MEMORY LOG OF THE METER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE TEST DID NOT START WHEN THE TEST STRIP WAS INSERTED INTO THEIR ADC BLOOD GLUCOSE METER AFTER BLOOD WAS APPLIED. CUSTOMER REPORTED USING AN AFFECTED TEST STRIP LOT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER REPORTED GETTING A READING ON THEIR FREESTYLE FREEDOM LITE METER THAT WAS HIGHER COMPARED TO HCP METER READING. IT WAS REPORTED THAT ON (B)(6), 2010 CUSTOMER RECEIVED A READING OF 65 MG/DL FROM THEIR FREESTYLE FREEDOM LITE METER AND FELT "STAGGERING, TIRED, INCOHERENT. " THE PARAMEDICS WERE CALLED, TREATED CUSTOMER WITH GLUCOSE GEL AND TRANSPORTED HIM TO A LOCAL HOSPITAL. THE READING OF 36 MG/DL WAS REPORTEDLY OBTAINED ON HCP METER OF UNKNOWN BRAND IN AN HOUR AFTER THE CUSTOMER REPORTED GETTING A READING OF 65 MG/DL. THE CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH SALINE INTRAVENOUS INFUSION AND "BREATHING TREATMENT. " THE CUSTOMER REPORTEDLY ALSO RECEIVED FOOD AT THE HOSPITAL TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0931816

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention