BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 3849144 · Received June 4, 2014

    Report

    Report Number
    2954323-2014-00630
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 4, 2014
    Report Date
    May 8, 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 Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREESTYLE TEST STRIP LOT THAT IS REFERENCED IN THIS MDR, ALTHOUGH UNKNOWN, 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: THE TEST STRIP LOT NUMBER IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO MDR 3004464228-2014-00610 RECEIVED FROM INSULET CORPORATION, A CUSTOMER REPORTED THAT ON (B)(6) 2014 AT 7:21 AM, SHE TESTED ON HER OMNIPOD SYSTEM USING FREESTYLE TEST STRIPS AND RECEIVED A READING OF 100 MG/DL. AT 8:00 AM, THE CUSTOMER "FELT SICK, HAD ABDOMINAL PAIN, AND WAS THROWING (UP)". CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM AND AND UPON HER ARRIVAL A BLOOD GLUCOSE COMPARISON WAS PERFORMED. CUSTOMER'S PDM REPORTEDLY READ 100 MG/DL AND THE HOSPITAL RESULT WAS GREATER THAN 500 MG/DL. CUSTOMER WAS TREATED WITH INSULIN INJECTIONS AND WAS HOSPITALIZED FOR 3 DAYS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327576 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization