BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3900796 · Received June 27, 2014

    Report

    Report Number
    2954323-2014-00731
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 7, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    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. THE ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. THE DATE LISTED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(6)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    A NURSE CALLING FROM A DIALYSIS CENTER REPORTED THAT APPROXIMATELY ONE WEEK PRIOR TO CALLING, A PATIENT WAS UNABLE TO RECEIVE A TEST RESULT WITH HIS ADC BLOOD GLUCOSE METER BECAUSE THE METER KEPT DISPLAYING ER-3 AND ER-4 MESSAGES. CALLER FURTHER REPORTED THE PATIENT WAS "SWEATING AND WAS IN SHOCK BECAUSE THE SUGAR WENT HIGH". IT WAS FURTHER REPORTED THE INDIVIDUAL SUBSEQUENTLY EXPERIENCED A LOSS OF CONSCIOUSNESS. THE PATIENT WAS RUSHED TO A LOCAL HEALTHCARE FACILITY WHERE HE WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH AN INSULIN INJECTION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377886 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1454926

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R