BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1655620 · Received April 9, 2010

    Report

    Report Number
    2954323-2010-00470
    Event Type
    Injury
    Date Received
    April 9, 2010
    Date of Event
    March 12, 2010
    Report Date
    April 9, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE PRODUCT IS RETURNED AND INVESTIGATION IS COMPLETE. NOTE: ON CASE (B) (4), CUSTOMER SERVICE WAS ABLE TO COMPLETE THE ERROR-3 TROUBLESHOOTING SURVEYS FOR BOTH METERS AND DURING THE TROUBLESHOOTING THE CUSTOMER WAS ABLE TO TEST HER BLOOD GLUCOSE ON BOTH METERS WITH NO ERROR MESSAGES. ON CASE (B) (4), THE CUSTOMER WAS UNABLE TO COMPLETE THE MEDICAL SURVEY AND CUSTOMER SERVICE MADE A FOLLOW-UP CALL TO THE CUSTOMER WHICH IS DOCUMENTED ON CASE (B) (4). NOTE: DEVICE MANUFACTURE DATE OF FREESTYLE LITE METER (B) (4) IS 12/10/2009. DEVICE MANUFACTURE DATE OF FREESTYLE FREEDOM METER (B) (4) IS 01/25/2009

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SHE RECEIVED AN ERROR-3 DISPLAY MESSAGE ON HER TWO BLOOD GLUCOSE METERS WHEN A TEST STRIP WAS INSERTED INTO THE PORT. THE REPORTED METERS WERE: FREESTYLE LITE METER (B) (4) WHEN TESTING WITH TEST STRIPS OF LOT # 0933728, AND FREESTYLE FREEDOM METER (B) (4) WHEN TESTING WITH TEST STRIPS OF AN UNKNOWN LOT NUMBER. THE CUSTOMER ALSO REPORTED SHE HAD AN INJURY, BUT REFUSED TO ANSWER ANY FURTHER SURVEY QUESTIONS. HOWEVER WHILE SHE WAS STILL TAKING TO CUSTOMER SERVICE SHE REPORTED "SHE WAS FINE". 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0933728

    Patients

    Seq Age Sex Outcome Treatment
    1 Other