BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3132891 · Received May 29, 2013

    Report

    Report Number
    2954323-2013-00292
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE METER WAS RETURNED AND INVESTIGATED WITH RETURNED TEST STRIPS. BLANK SCREEN WAS OBSERVED USING CUSTOMER'S BATTERY. RETURNED BATTERY WAS REPLACED WITH A NEW BATTERY AND BLANK SCREEN WAS RESOLVED. METER POWERED ON WITH BUTTON PRESS AND TEST STRIP INSERTION. POWER ISSUE WITH STRIP PORT WAS NOT OBSERVED. NO NEW ISSUES WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. NOTE: THE ACTUAL DATE OF THE REPORTED MEDICAL EVENT IS UNKNOWN. THE EVENT DATE ENTERED IS THE COMPLAINT AWARENESS DATE. .

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING UNABLE TO TEST DUE TO HER ADC BLOOD GLUCOSE METER NOT POWERING ON WITH TEST STRIP INSERTION. CUSTOMER FURTHER REPORTED THAT WHILE LYING ON HER BED, PRIOR TO ATTEMPTING TO TEST, SHE EXPERIENCED MULTIPLE SYMPTOMS DESCRIBED AS "THIRST, DRIED THROAT, HEADACHE, AND WOOZY". CUSTOMER SELF-TREATED WITH WATER AND METFORMIN 500 MG. PARAMEDICS WERE CONTACTED AND CUSTOMER WAS TRANSPORTED TO A LOCAL HOSPITAL WHERE SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND TREATED WITH UNSPECIFIED INTRAVENOUS FLUIDS AND UNSPECIFIED INTRAVENOUS MEDICATION FOR PAIN. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND ADMINISTERED INSULIN, A NEW, NOT PREVIOUSLY PRESCRIBED MEDICATION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234482 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1259616

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R