BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 4090738 · Received September 15, 2014

    Report

    Report Number
    2954323-2014-00968
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    May 17, 2014
    Report Date
    August 21, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS CONTACTED IN FOLLOW-UP AND PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER REPORTED SHE HAD CHECKED HER GLUCOSE ON (B)(6) 2014 USING HER OMNIPOD DEVICE AND RECEIVED A READING OF "305 MG/DL AROUND NOONTIME AND THEN TESTED AGAIN ALSO AROUND NOONTIME AND RECEIVED A READING OF 250 MG/DL, PRIOR TO BEING RUSHED TO THE HOSPITAL". CUSTOMER BELIEVED THAT BOTH OF THESE READINGS WERE "HIGH".

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE FREESTYLE TEST STRIP LOT THAT IS REFERENCED IN THIS MDR IS UNKNOWN. HOWEVER, THE FREESTYLE SYSTEM MAY BE 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. THE DEVICE MANUFACTURER DATE IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2014, SHE RECEIVED AN UNSPECIFIED READING ON HER OMNIPOD INSULIN PUMP, WHILE USING FREESTYLE TEST STRIPS, WHICH WAS LOWER THAN A SUBSEQUENT READING OF 275 MG/DL RECEIVED ON A HOSPITAL DEVICE. CUSTOMER FURTHER REPORTED SHE FELT "SICK AND WEAK", HAD "CHEST PAIN", "COULDN'T BREATHE" AND (HER) STOMACH WAS UPSET". CUSTOMER WAS TAKEN TO A LOCAL HEALTHCARE FACILITY, WHERE A READING OF 275 MG/DL WAS RECEIVED IN THE EMERGENCY ROOM. CUSTOMER WAS DIAGNOSED WITH DKA (DIABETIC KETOACIDOSIS) AND WAS TREATED WITH INSULIN AND ELECTROLYTES VIA INTRAVENOUS INFUSION, IN ADDITION TO RECEIVING "MEDICATIONS" WHICH SHE COULD NOT NAME. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570321 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention