BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE INSULINX

    MDR report key: 3924289 · Received July 9, 2014

    Report

    Report Number
    2954323-2014-00754
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 12, 2014
    Product Code
    NBW
    PMA / PMN Number
    K120568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: ALTHOUGH THE REPORTED READING OF 91 MG/DL IS INCONSISTENT WITH THE REPORTED DIAGNOSIS OF SEVERE HYPOGLYCEMIA, IT IS ASSUMED, UNDER THE REPORTED CIRCUMSTANCES, THE PARAMEDIC ADMINISTERED SOME TREATMENT OF GLUCOSE TO THE CUSTOMER. 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

    CALLER (CUSTOMER'S WIFE) REPORTED THAT ON (B)(6), 2014, AT APPROXIMATELY 15:00, THE CUSTOMER OBTAINED A READING OF 327 MG/DL ON THE ADC BLOOD GLUCOSE METER. THE CUSTOMER SUBSEQUENTLY SELF-INJECTED AN UNSPECIFIED DOSE OF INSULIN PRIOR TO EATING AT APPROXIMATELY 15:30. AT APPROXIMATELY 17:00, THE CUSTOMER REPORTEDLY LOST CONSCIOUSNESS WHILE DRIVING AND WAS INVOLVED IN A TRAFFIC COLLISION. PARAMEDICS WERE CALLED AND THE CUSTOMER WAS TRANSPORTED TO A LOCAL HOSPITAL, WHERE A LABORATORY RESULT OF 91 MG/DL WAS OBTAINED AT 19:30 AND HE WAS DIAGNOSED WITH HYPOGLYCEMIA. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER'S DAUGHTER INDICATED THE CUSTOMER WAS REPORTEDLY "SUBJECTED TO SURGERY" ON (B)(6), 2014 AND RELEASED FROM THE HOSPITAL ON (B)(6), 2014. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399700 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| O| R