BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE INSULINX

    MDR report key: 3870779 · Received June 12, 2014

    Report

    Report Number
    2954323-2014-00656
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 19, 2014
    Product Code
    NBW
    PMA / PMN Number
    K120568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED AND NO TEST STRIP LOT WAS REPORTED WITH THIS COMPLAINT, A DEVICE HISTORY REVIEW (DHR) OF THE METER WAS REQUESTED. THE DHR FOR METER SERIAL NUMBER (B)(4) INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2014 HE/SHE RECEIVED THE FOLLOWING READINGS FROM THEIR ADC BLOOD GLUCOSE METER, WHICH WERE HIGHER THAN A SUBSEQUENT READING OBTAINED AT A HOSPITAL: 448 MG/DL AT 10:10 AM AND 426 MG/DL AT 10:30 AM. IT WAS FURTHER REPORTED THE CUSTOMER EXPERIENCED "DIZZINESS, SWEATING, SHAKING AND BLURRED VISION". CUSTOMER SELF-PRESENTED TO A LOCAL HEALTHCARE FACILITY WHERE A READING OF 36 MG/DL WAS OBTAINED ON A COMPETITOR'S METER AT 12:30 PM. THE COMPLAINT ALSO MENTIONS A "LAB" COMPARISON, BUT NO ADDITIONAL READINGS WERE PROVIDED. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH A GLUCAGON INJECTION, IN ADDITION TO RECEIVING "GLUCOSE SERUM, VENOUS INJECTION". 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
    346911 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention