BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3781899 · Received April 30, 2014

    Report

    Report Number
    2954323-2014-00474
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 1, 2014
    Report Date
    April 8, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Removal / Correction Number
    ADC FA1002-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT SHOULD BE NOTED: CUSTOMER WAS USING FREESTYLE LITE TEST STRIPS WHICH ARE NOT COMPATIBLE FOR USE WITH THE OMNIPOD INSULIN PUMP. ADDITIONALLY: THE READING OF 22 MG/DL IS CONSISTENT WITH THE NEED TO TREAT WITH GLUCAGON. IT SHOULD ALSO BE NOTED: THE CUSTOMER HAS A PRE-EXISTING SEIZURE DISORDER. 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. THE ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A LOW READING ON HER OMNIPOD INSULIN PUMP WHILE USING TEST STRIPS INVOLVED IN THE RECENT RECALL. CUSTOMER FURTHER REPORTED THAT SOMETIME IN (B)(6), 2014 SHE RECEIVED A READING OF 22 MG/DL, EXPERIENCED, "DIZZINESS" AND SUBSEQUENTLY A "SEIZURE". PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH AN INTRAVENOUS INFUSION OF UNKNOWN TYPE "FOR (HER) SEIZURE" IN ADDITION TO ADMINISTERING GLUCAGON VIA INJECTION. IT WAS FURTHER REPORTED A READING OF 150 MG/DL WAS RECEIVED ON A HEALTHCARE PROVIDER'S METER, TWO HOURS AFTER THE RESULT FROM HER OMNIPOD AND POST-TREATMENT WITH GLUCAGON. CUSTOMER WAS REPORTEDLY DIAGNOSED WITH HYPOGLYCEMIA. NO ADDITIONAL TREATMENT WAS REPORTED. CUSTOMER ALSO REPORTED RECEIVING A READING OF 520 MG/DL ON HER OMNIPOD, BUT IT IS UNKNOWN WHEN THIS READING WAS OBTAINED RELATIVE TO THE OTHER REPORTED READING AND SUBSEQUENT TREATMENT. MULTIPLE ATTEMPTS TO CONTACT CUSTOMER TO GATHER ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259336 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1361325

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R