BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 3849071 · Received June 4, 2014

    Report

    Report Number
    2954323-2014-00629
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    February 10, 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; THEREFORE, THE DEVICE MANUFACTURER DATE IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO MDR 3004464228-2014-00626 RECEIVED FROM INSULET CORPORATION, CUSTOMER REPORTED SHE WAS HOSPITALIZED ON (B)(6) 2014 FOR DIABETIC KETOACIDOSIS (DKA) DUE TO HER OMNIPOD SYSTEM PROVIDING "LOWER AND INCONSISTENT BG READINGS" WHEN USED WITH FREESTYLE TEST STRIPS. CUSTOMER FURTHER REPORTED SHE WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2014 BUT DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING HER HOSPITALIZATION OR HER TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327767 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization