BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3092420 · Received May 3, 2013

    Report

    Report Number
    2954323-2013-00251
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 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. THE ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. THE RETURNED METER POWERED ON WITH BUTTON PRESS AND STRIP INSERTION. A BLANK SCREEN WAS NOT OBSERVED. NO NEW ISSUES WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TWO AND A HALF WEEKS 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. CUSTOMER FURTHER REPORTED THAT AT THAT TIME SHE EXPERIENCED "SHAKINESS, WEAKNESS, SWEATINESS AND SHORTNESS OF BREATH". CUSTOMER NOTED SHE ATTEMPTED TO SELF-TREAT WITH CANDY, BUT THEN EXPERIENCED BOTH A LOSS OF CONSCIOUSNESS AND A SEIZURE. WHEN SHE "CAME BACK TO SENSES" HER HUSBAND GAVE HER FOOD TO EAT. CUSTOMER CONTACTED HER HEALTHCARE PROVIDER WHO DIAGNOSED HER WITH "SEVERE LOW BLOOD SUGAR" AND ADVISED HER TO HOLD HER INSULIN UNTIL CONSULTING WITH HER ENDOCRINOLOGIST WHO DECREASED HER INSULIN TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194969 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1178769

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other