BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 2191797 · Received August 4, 2011

    Report

    Report Number
    2954323-2011-04104
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 4, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE MEDICAL EVENT WAS RELATED TO CUSTOMER USING AN EXPIRED TEST STRIPS. THEREFORE NO FURTHER INVESTIGATION OF THE PRODUCT IS REQUIRED. THE DATE OF MANUFACTURE IS UNKNOWN. THE DATE LISTED IN SECTION H-4 IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. IN ADDITION, PRECISION METERS WILL DISPLAY ERROR 6 MESSAGE IF AN EXPIRED TEST STRIP IS USED. IN THIS CASE, THE CUSTOMER USED AN EXPIRED TEST STRIPS.

    Description of Event or Problem · 1

    CUSTOMER'S FRIEND REPORTED THAT THE CUSTOMER WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL BECAUSE OF THE ERROR 6 MESSAGE ON HER ADC BLOOD GLUCOSE METER. THE CALLER FURTHER REPORTED THAT THE CUSTOMER "GOTTEN UP" FROM A CHAIR, SEEING "STARS AND SPARKLES", AND THEN SHE LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND RESPONDED. PARAMEDICS INITIATED AN IV AND TRANSPORTED THE CUSTOMER TO THE HOSPITAL. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH UNSPECIFIED FLUIDS VIA INTRAVENOUS ROUTE AND SHE WAS ALSO GIVEN ORANGE JUICE. 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 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 44528

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R