BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1882100 · Received October 25, 2010

    Report

    Report Number
    2954323-2010-01481
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 25, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THIS CASE DOES NOT INVOLVE A PRODUCT MALFUNCTION. BLOOD WAS INSERTED INTO THE PORT. SINCE THE MEDICAL EVENT WAS RELATED TO A USER ERROR, NO INVESTIGATION OF THE PRODUCT IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CALLED IN ON 09/28/2010 REPORTING THEY DID NOT RECEIVE THEIR METER ORDERED ON (B)(6) 2010. THE CUSTOMER FURTHER REPORTED ON (B)(6) 2010 AT 9:00 AM THE CUSTOMER HAD A PRODUCT ISSUE THAT LED UP TO THE MEDICAL EPISODE OCCURRED ON (B)(6) 2010 AT 10:00 AM. ALTHOUGH THE CUSTOMER STATED THE MEDICAL EVENT WAS RELATED TO A DELIVERY DELAY, THE TIME-FRAME SUGGESTS THAT THE MEDICAL INCIDENT WAS RELATED TO A "TEST DOES NOT START AFTER SAMPLE APPLIED" ISSUE REPORTED IN CASE (B)(4) ON (B)(6) 2010. THE CUSTOMER STATED THEY WERE UNABLE TO USE THEIR METER AS THEY PUT BLOOD IN THE METER AND AS A RESULT OF BEING UNABLE TO TEST, SHE FELT "HOT, DIZZY, AND LIKE SHE WAS GOING TO PASS OUT. "SHE REPORTEDLY WAS SEEN BY A DOCTOR, DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN. IT'S UNKNOWN IF THE INSULIN WAS A PART OF THE CUSTOMER'S REGULAR DIABETES REGIMEN. THE CUSTOMER ALSO REPORTED SELF-TREATING WITH "GLUBSIDE", ANTIHYPERTENSIVE MEDICATION AND WATER TO ALLEVIATE THE SYMPTOMS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention