BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 3840706 · Received May 30, 2014

    Report

    Report Number
    2954323-2014-00599
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Removal / Correction Number
    ADC FA1002-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT 1376264 WAS MENTIONED AS AN ADDITIONAL LOT NUMBER AND AT THIS TIME IT IS UNKNOWN IF THE CUSTOMER WAS EXPERIENCING THE SAME ISSUE. HOWEVER, 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: 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 THEIR OMNIPOD SYSTEM GAVE AN INACCURATE LOW READING WHEN USED WITH FREESTYLE LITE TEST STRIPS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319005 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1376264

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR