BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2011192 · Received March 8, 2011

    Report

    Report Number
    2954323-2011-02124
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    May 31, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE ORIGINAL MDR SHOULD HAVE BEEN SENT AS A FINAL REPORT. THE COMPLAINT INVOLVED A TRAINING ISSUE. THERE WAS NO INDICATION OF A PRODUCT PROBLEM, HENCE NO PRODUCT INVESTIGATION WILL BE UNDERTAKEN.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED THAT DUE TO NOT SETTING UP THEIR METER FOR USE THEY EXPERIENCED SYMPTOMS OF SWEATINESS, HAD "HIGH BLOOD PRESSURE" SUBSEQUENTLY REPORTED EXPERIENCING A LOSS OF CONSCIOUSNESS AND "SHAKES" WHILE AT HOME. CUSTOMER WAS NOT SEEN AT A HEALTH CARE FACILITY, NO DIAGNOSIS WAS REPORTED. CUSTOMER STATED HE WAS GIVEN ORANGE JUICE AND GLUCOSE TABLETS AS A TREATMENT WHICH REPORTEDLY "WAS SUCCESSFUL." THE CUSTOMER FURTHER REPORTED HE SAW HIS PHYSICIAN THE FOLLOWING DAY BUT "RECEIVED NO TREATMENT AS THE ISSUE HAD BEEN RESOLVED AT THAT TIME." THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other