BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2457968 · Received February 16, 2012

    Report

    Report Number
    2954323-2012-05890
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    January 23, 2012
    Report Date
    May 16, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN TESTING WAS REQUESTED FOR THE REPORTED TEST STRIPS. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1173855) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2012 SHE RECEIVED A READING OF 136 MG/DL ON HER ADC BLOOD GLUCOSE METER WHICH WAS LOWER THAT SHE FELT. CUSTOMER ALSO REPORTED RECEIVING A READING OF 269 MG/DL ON (B)(6) 2012 ON HER ADC METER WHICH WAS HIGHER THAN SHE FELT. CUSTOMER FURTHER REPORTED THAT ON (B)(6) 2012 SHE STARTED EXPERIENCING SYMPTOMS OF "CONFUSION AND NOT HER USUAL SELF." THE CUSTOMER THEN TESTED HER BLOOD GLUCOSE LEVEL AND RECEIVED A READING OF 189 MG/DL ON HER ADC BLOOD GLUCOSE METER WHICH WAS LOWER THAN SHE FELT. THE CUSTOMER NOTED THAT SHE BELIEVED THE SYMPTOMS SHE EXPERIENCED ON (B)(6) 2012 WERE RELATED TO READINGS THAT SHE RECEIVED STARTING (B)(6) 2011. CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND DENIED SELF-TREATMENT. PARAMEDICS WERE CALLED AND RECEIVED A READING OF 40 MG/DL ON THE HCP METER. THE CUSTOMER WAS TREATED ON THE SCENE WITH "ORAL GLUCOSE AND ORANGE JUICE." THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1173855

    Patients

    Seq Age Sex Outcome Treatment
    1 Other