BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2806338 · Received October 26, 2012

    Report

    Report Number
    2954323-2012-06673
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 5, 2012
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS (LOT 1183009). METER POWERED ON WITH BUTTON AND WITH INSERTION OF STRIPS. DID NOT OBSERVE METER TURN ON THEN OFF AFTER STRIPS WERE INSERTED. NO NEW ISSUES WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PORT ISSUE WITH HIS ADC BLOOD GLUCOSE METER, WHICH PREVENTED HIM FROM RECEIVING A GLUCOSE RESULT. CUSTOMER FURTHER REPORTED THAT ON (B)(6) 2012 WHILE HE WAS DRIVING HE BEGAN TO FEEL "TERRIBLE" SO HE STOPPED HIS CAR AND EXPERIENCED A LOSS OF CONSCIOUSNESS. SOMEONE CAME TO HIS ASSISTANCE AND HE WAS TAKEN HOME. PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL ADMINISTERED "AN INJECTION FOR HIS SUGAR" AND THEN GAVE HIM FOOD TO EAT. 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
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1257223

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R