BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1862696 · Received October 8, 2010

    Report

    Report Number
    2954323-2010-01409
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 19, 2010
    Report Date
    October 8, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: DURING THE TROUBLESHOOTING SURVEY, IT WAS ADDITIONALLY IDENTIFIED BY (B)(4) CUSTOMER SERVICE THAT: THE CUSTOMER DID NOT INSTALL NEW BATTERIES IN HIS METER AND DID NOT HAVE NEW BATTERIES AVAILABLE FOR REPLACEMENT. (B)(4) CUSTOMER SERVICE EDUCATED THE CUSTOMER ABOUT BATTERY REPLACEMENT. THE REPORTED TEST STRIP LOT WAS INCOMPATIBLE WITH THE CUSTOMER'S DEVICE (LOT # 0933729; FS CLASSIC).

    Description of Event or Problem · 1

    THE CUSTOMER'S FAMILY MEMBER REPORTED THE CUSTOMER'S FREESTYLE LITE BLOOD GLUCOSE METER WOULD NOT TURN ON WHEN THE BUTTON WAS PRESSED AND WHEN A TEST STRIP WAS INSERTED INTO THE PORT. THE CUSTOMER'S FAMILY MEMBER ALSO REPORTED THE CUSTOMER EXPERIENCED CHEST PAIN, "HIGH SUGAR LEVEL", FATIGUE AND LOSS OF CONSCIOUSNESS. THE PARAMEDICS WERE CALLED AND TREATED THE CUSTOMER WITH THE MEDICATION LANTUS. ALTHOUGH IT WAS REPORTED THE CUSTOMER WAS TRANSPORTED TO A HEALTH CARE FACILITY, IT IS UNKNOWN THE MEDICAL DIAGNOSIS AND IF THE CUSTOMER RECEIVED FURTHER TREATMENT AT THE FACILITY. 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 0933729

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R