BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1933552 · Received December 20, 2010

    Report

    Report Number
    2954323-2010-01701
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 2, 2010
    Report Date
    February 25, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER (B)(4) WAS RETURNED AND INVESTIGATED. THE PORT ISSUE WAS CONFIRMED. THE METER WAS DISASSEMBLED AND A RAISED PIN (#5) WAS OBSERVED IN THE STRIP PORT. NO ADDITIONAL ISSUES WERE IDENTIFIED DURING EXTENDED PRODUCT INVESTIGATION. THE PINS LOCATED IN THE STRIP PORT ALIGN WITH THE ELECTRODES ON THE TEST STRIP, IF ONE OF THE PINS IS BENT OR RAISED, THE TEST WILL NOT BE CONDUCTED. ALTHOUGH GLUCOSE RESULTS MAY BE DELAYED, BLOOD GLUCOSE COULD BE DETERMINED BY ALTERNATE MEANS, INCLUDING USE OF ANOTHER BLOOD GLUCOSE METER, SEEING A PHYSICIAN (AS RECOMMENDED IN PRODUCT LABELING), OR BY SEEKING TREATMENT AT A HEALTH CARE FACILITY. THIS ISSUE IS CURRENTLY TRACKED AND TRENDED. NO SPECIFIC CAUSE OF PIN DAMAGE HAS BEEN IDENTIFIED FOR THIS COMPLAINT. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED THAT WHEN SHE APPLIES HER BLOOD TO THE TEST STRIP, THE TEST DOES NOT START IN HER FS FREEDOM LITE METER. CUSTOMER FURTHER REPORTED THAT ON (B)(6) 2010 AT 0737 WHEN SHE ATTEMPTED TO TEST, SHE STATED SHE "BEGAN TO BLACKOUT". CUSTOMER DENIED A LOSS OF CONSCIOUSNESS OR SEIZURE OCCURRED HOWEVER, PARAMEDICS WERE CALLED AND SHE WAS TRANSPORTED TO A HEALTH CARE FACILITY. CUSTOMER COULD NOT RECALL A DIAGNOSIS GIVEN AND STATED SHE WAS TREATED WITH FOOD AND INTRAVENOUS FLUIDS (TYPE OF SOLUTION UNKNOWN). NO ADDITIONAL INFORMATION WAS PROVIDED. 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 1025121

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention