BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3013642 · Received March 20, 2013

    Report

    Report Number
    2954323-2013-00164
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    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 ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT APPROXIMATELY THREE MONTHS PRIOR TO CALLING CUSTOMER SERVICE ON (B)(6) 2013, HER ADC BLOOD GLUCOSE METER WOULD NOT TURN ON WHEN THE BUTTON WAS PRESSED OR WITH TEST STRIP INSERTION (BLANK SCREEN). CUSTOMER FURTHER REPORTED THAT ON (B)(6) 2013, WHILE EATING AT A RESTAURANT SHE BEGAN TO FEEL "VERY THIRSTY" AND "SWEATY" AND SUBSEQUENTLY EXPERIENCED A LOSS OF CONSCIOUSNESS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER DENIED SELF-TREATING. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116632 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1254638

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other