BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 4090590 · Received September 15, 2014

    Report

    Report Number
    2954323-2014-00966
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE COMPLAINT INVOLVED A TRAINING ISSUE, HENCE NO PRODUCT INVESTIGATION WILL BE UNDERTAKEN. LABEL COPY INSTRUCTS CUSTOMERS ON HOW TO PROPERLY SET UP THE ADC METER. NOTE: THE DATE OF EVENT IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED CUSTOMER SERVICE TO REQUEST ASSISTANCE SETTING UP HIS ADC BLOOD GLUCOSE METER. CUSTOMER FURTHER REPORTED SELF-INJECTING GLUCAGON AS A RESULT OF THE DATE AND TIME NOT BEING SET IN HIS METER. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER AS HE DECLINED TO CONTINUE TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570271 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention