BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 3222349 · Received July 12, 2013

    Report

    Report Number
    2954323-2013-00370
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    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

    THE INITIAL 30-DAY REPORT WAS POPULATED AS 'FREESTYLE FREEDOM LITE' INCORRECTLY. CORRECT BRAND NAME IS FREESTYLE FREEDOM AND SECTION D1 HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE ACTUAL DATE OF THE REPORTED MEDICAL EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE COMPLAINT AWARENESS DATE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE WAS UNABLE TO TEST WITH HIS ADC BLOOD GLUCOSE METER DUE TO THE TEST NOT STARTING AFTER THE BLOOD SAMPLE WAS APPLIED. CUSTOMER REPORTED THAT 2 WEEKS PRIOR TO CONTACTING ADC CUSTOMER SERVICE HE WAS AT A BASKETBALL GAME EATING PIZZA WHEN AT APPROXIMATELY 9:00 P.M "HE TRIED TO TEST HIS BLOOD SUGAR FOR ABOUT 5 - 6 TIMES BUT HE GOT NO RESULT FROM THE METER". CUSTOMER MENTIONED "HE IS USUALLY (TAKES) 18 UNITS OF (NOVOLOG) INSULIN BUT BECAUSE OF WHAT HE ATE, HE ADDED EXTRA DOSE OF INSULIN AND MADE IT 24 UNITS". CUSTOMER WENT HOME, SLEPT, AND REPORTEDLY EXPERIENCED A SEIZURE BETWEEN THE HOURS OF MIDNIGHT AND 3:00 A.M. AND BIT HIS TONGUE. CUSTOMER FURTHER REPORTED HIS "PARENTS GAVE HIM FOOD AND BEVERAGE" AND AT AROUND 4:00 A.M HE "DID A TEST USING HIS OTHER METER AND GOT A RESULT OF 165MG/DL". THE FOLLOWING DAY, THE CUSTOMER "TOOK PAIN MEDICATION IN THE FORM OF GEL" FOR HIS TONGUE AND SELF-PRESENTED TO HIS DOCTOR WHERE HE WAS ADVISED TO "KEEP ON TESTING HIS BLOOD SUGAR AND TO BE CAREFUL WITH WHAT HE EATS AND TO CONTINUE WITH THE GEL FOR HIS TONGUE AND TO DRINK SALT WATER". CUSTOMER ADDITIONALLY MENTIONED HE HAS A HISTORY OF SEIZING "WHENEVER HIS BLOOD SUGAR IS LOW". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323904 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 1276132

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other