BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2112071 · Received June 2, 2011

    Report

    Report Number
    2954323-2011-03471
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    March 21, 2011
    Report Date
    August 8, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(4)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE. THE CUSTOMER WAS CONTACTED BY ADC CUSTOMER SERVICE AND STATED THAT SHE DOES NOT KNOW THE READINGS, DATES AND TIMES THAT CAUSED HER MEDICAL ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED STARTING (B)(6) 2011 AT 9:00AM, SHE EXPERIENCED LIGHTHEADEDNESS AND VERTIGO ON AND OFF OVER THE (B)(6). THE CUSTOMER REPORTEDLY LOST CONSCIOUSNESS AND PARAMEDICS WERE CALLED ON (B)(6) 2011, INITIATED AN INTRAVENOUS INFUSION , PROVIDED OXYGEN AND TRANSPORTED HER TO THE HOSPITAL WHERE SHE WAS ADMITTED WITH DKA, CONTINUED ON IV TREATMENT OF UNKNOWN TYPE AND RELEASED ON (B)(6) 2011. THE CUSTOMER ALSO SELF-TREATED WITH INSULIN AND PERCOCET. 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 1027114

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R