BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 3665797 · Received March 6, 2014

    Report

    Report Number
    2954323-2014-00205
    Event Type
    Injury
    Date Received
    March 6, 2014
    Date of Event
    November 18, 2013
    Report Date
    February 6, 2014
    Product Code
    LFR
    PMA / PMN Number
    K092638
    Removal / Correction Number
    ADC FA1002-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREESTYLE TEST STRIP LOT THAT IS REFERENCED IN THIS MDR IS ASSOCIATED WITH AN ON-GOING RECALL. THE FDA WAS INFORMED OF THE FIELD ACTION PER 21CFR806 (RECALL NUMBER 2954323-02/07/14-001-R) AND AFFECTED CONSIGNEES WERE NOTIFIED BY LETTER BEGINNING FEBRUARY 19, 2014. ADC HAS IDENTIFIED THAT ALL NON-APPLIED VOLTAGE LEGACY BLOOD GLUCOSE METERS (0MV) MAY PRODUCE ERRONEOUSLY LOW BLOOD GLUCOSE READINGS IN THE PARKES ERROR GRID C OR D ZONE THAT COULD POTENTIALLY AFFECT CLINICAL OUTCOME WHEN USED IN CONJUNCTION WITH FREESTYLE TEST STRIP LOT WITHIN EXPIRY. THIS ISSUE ONLY OCCURS WHEN FREESTYLE OR FREESTYLE LITE BLOOD GLUCOSE TEST STRIPS ARE USED WITH FREESTYLE, FREESTYLE FLASH BLOOD GLUCOSE METERS AND THE FREESTYLE BLOOD GLUCOSE METER BUILT INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEM AND FREESTYLE NAVIGATOR. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER HAS NOT BEEN WEARING A POD FOR SEVERAL DAYS AND THE MOST RECENT POD PLACED WAS (B)(6) 2013. THE CUSTOMER HAS BEEN CHECKING HIS BG (BLOOD GLUCOSE) LEVELS BUT DOES NOT WANT TO OR DOES NOT FIND IT NECESSARY TO WEAR A POD, FOR HIS BG RESULTS HAVE BEEN SHOWING IN NORMAL RANGE. THE CUSTOMER HAS BEEN USING THE FREESTYLE STRIPS WITH LOT NUMBER 1357949. THE CUSTOMER'S FASTING A1C WAS 13 AND BG LEVEL WAS 558 MG/DL FOR (B)(6) 2013. THE CUSTOMER HAD 4 LOOSE STOOLS, FREQUENT URINATION, FEELING TIRED, VERY THIRSTY AND HUNGRY WHILE AT SCHOOL, AND WHEN HIS MOM HEARD THE RESULTS SHE TOOK HIM TO THE ER. THE CUSTOMER HAS HAD FLUIDS STARTED AND RECEIVED 4U IN THE ABDOMEN. THE CUSTOMER'S MOTHER IS CONCERNED THE PDM IS NOT READING RESULTS CORRECTLY. DAILY AVERAGE OF BG LEVELS FROM PDM AS FOLLOWS: (B)(6) 2013=HIGH; (B)(6) 2013=144; (B)(6) 2013=142; (B)(6) 2013=ZERO READINGS TAKEN PER CUSTOMER'S CHOICE; (B)(6) 2013=152; (B)(6) 2013=135. (B)(6) 2013=134; (B)(6) 2013=128; (B)(6) 2013=145.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135820 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR 1357949

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention