BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 4141232 · Received October 3, 2014

    Report

    Report Number
    2954323-2014-01005
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    October 20, 2009
    Report Date
    September 8, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Removal / Correction Number
    ADC FA1002-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    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. NOTE: A READING OF 350 MG/DL IS INDICATIVE OF HYPERGLYCEMIA AND IS NOT INCONSISTENT WITH THE REPORTED ELEVATED HEMOGLOBIN A1C AND DIAGNOSIS OF HYPERGLYCEMIA. ADDITIONALLY, FREESTYLE LITE TEST STRIPS ARE NOT COMPATIBLE WITH THE OMNIPOD SYSTEM. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING A USER OF THE OMNIPOD SYSTEM SINCE (B)(6) 2009 AND STATED THAT BEGINNING (B)(6) 2009, SHE EXPERIENCED ELEVATED BLOOD GLUCOSE, ELEVATED CPK LEVEL, MUSCLE FATIGUE, HEART PALPITATIONS, AND STATED HER "HEMOGLOBIN A1C NEVER BEEN BELOW 11 WHICH IS HIGHER THAN NORMAL". CUSTOMER ADDITIONALLY REPORTED THE OMNIPOD SYSTEM, WHEN USED WITH FS LITE TEST STRIPS, PROVIDED HER A READING OF 350 MG/DL FOR "OVER A WEEK". CUSTOMER SELF-PRESENTED TO A LOCAL HOSPITAL WHERE UNSPECIFIED READINGS "LOWER THAN THE READINGS IN THE OMNIPOD" WERE OBTAINED AND SHE WAS DIAGNOSED WITH HYPERGLYCEMIA, REPORTEDLY PUT ON AN INSULIN PUMP, AND TREATED WITH AN INSULIN INJECTION, UNSPECIFIED INTRAVENOUS FLUIDS, AND UNSPECIFIED ORAL MEDICATION. THERE WAS NO DEATH, SERIOUS INJURY OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620777 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1368665

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR