BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2069874 · Received April 26, 2011

    Report

    Report Number
    2954323-2011-03068
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 2, 2011
    Report Date
    July 26, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP REPORT #2 INCORRECTLY READ (B)(6) 2011. THE CORRECT DATE RECEIVED BY MANUFACTURER IS (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. SOME OF THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1024218) 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 INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER'S FAMILY MEMBER REPORTED RECEIVING READINGS OF 73MG/DL, 247MG/DL, 107MG/DL, 118MG/DL, 53MG/DL AND 66 MG/DL ON (B)(6) 2011 THAT THEY PERCEIVED AS ERRATIC, HOWEVER NONE OF THE READINGS WERE OBTAINED WITHIN 10 MINUTES, HENCE ARE INVALID FOR COMPARISON. THE CALLER FURTHER REPORTED HER MOTHER WAS "ACTING STRANGE" AS SHE WAS "SWEATY, PALE, DAZED, CONFUSED" WHEN SHE CALLED PARAMEDICS. THE CUSTOMER REPORTEDLY "WAS GIVEN A SHOOT OF SOMETHING AND SHE ATE PEANUT BUTTER " TO COUNTERACT THE EVENT. THE CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY. 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 1024218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention