BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2173973 · Received July 24, 2011

    Report

    Report Number
    2954323-2011-03927
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    March 29, 2011
    Report Date
    July 19, 2011
    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 AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER'S SPOUSE REPORTED THE CUSTOMER RECEIVED A BLANK SCREEN ON HIS FREESTYLE LITE METER. THE CALLER REPORTED THAT ON (B)(6) 2011 AT 4:00PM THE CUSTOMER EXPERIENCED A "MINOR STROKE", AND WAS HOSPITALIZED FOR (B)(6). THE CALLER FURTHER REPORTED THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS. THE CUSTOMER SELF-PRESENTED TO A HEALTH CARE FACILITY, AND WAS DIAGNOSED WITH HYPERGLYCEMIA. THE CALLER REPORTED THE CUSTOMER WAS TREATED WITH INSULIN AND PLAVIX (CLOPIDOGREL) IN ADDITION TO OCCUPATIONAL AND SPEECH THERAPY. THE CALLER REPORTED THE CUSTOMER SELF-TREATED WITH GLYBURIDE 4 TIMES PER DAY, ONGLYZA (SAXAGLIPTIN) 5MG, AND ASPIRIN. THE CALLER ALSO REPORTED THE CUSTOMER WAS "GIVEN PUREED FOOD" TO COUNTERACT THE EVENT. THERE IS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0931328

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R