BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2930609 · Received January 28, 2013

    Report

    Report Number
    2954323-2013-00061
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 6, 2013
    Product Code
    NBW
    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. 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.

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATION REVEALED A FAST DRAINING BATTERY DUE TO A CAPACITOR. NO ADDITIONAL ISSUES WERE OBSERVED DURING PRODUCT INVESTIGATION. THE METER'S DISPLAY FLASHES A LOW BATTERY ICON TO WARN THE USER OF THE NEED TO REPLACE THE BATTERIES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FAST-DRAINING BATTERY ISSUE AND A BLANK SCREEN ISSUE WITH HER ADC BLOOD GLUCOSE METER. CUSTOMER FURTHER REPORTED THAT DUE TO THESE ISSUES SHE COULD NOT TEST AND "IS IN DANGER OF GOING BLIND, NOT KNOWING IF (HER) BLOOD SUGAR IS HIGH OR LOW". CUSTOMER FURTHER REPORTED EXPERIENCING AN UNSPECIFIED INJURY AS A RESULT OF THIS. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER AS SHE DECLINED TO CONTINUE TROUBLESHOOTING. MULTIPLE, UNSUCCESSFUL, ATTEMPTS TO CONTACT CUSTOMER TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37062 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1258018

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other