BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3953034 · Received July 23, 2014

    Report

    Report Number
    2954323-2014-00798
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED AND TEST STRIP LOT REPORTED WITH THIS COMPLAINT IS EXPIRED, 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.

    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: DURING THE COURSE OF TROUBLESHOOTING IT WAS IDENTIFIED THE CUSTOMER WAS USING EXPIRED TEST STRIPS (FEB 2014) TO TEST. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING UNABLE TO TEST WITH HER ADC BLOOD GLUCOSE METER DUE TO THE TEST NOT STARTING AFTER THE BLOOD SAMPLE WAS APPLIED. CUSTOMER FURTHER REPORTED THAT ON (B)(6), 2013, SHORTLY BEFORE 3:00P.M., SHE WAS "CONFUSED AND INCOHERENT". PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL, EMT TREATED THE PATIENT WITH "SUGAR WATER VIA NEEDLE". CUSTOMER WAS TRANSPORTED TO A LOCAL HOSPITAL WHERE SHE WAS REPORTEDLY ADVISED BY A DOCTOR TO REDUCE HER INSULIN INTAKE, HOWEVER THERE WAS NO REPORT OF ADDITIONAL TREATMENT OR DIABETIC DIAGNOSIS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430370 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1254420

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention