BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3800894 · Received May 8, 2014

    Report

    Report Number
    2954323-2014-00518
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1450755) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CALLER (CUSTOMER'S DAUGHTER-IN-LAW) REPORTED THE CUSTOMER WAS UNABLE TO TEST WITH HIS ADC BLOOD GLUCOSE METER DUE TO THE TEST NOT STARTING AFTER THE BLOOD SAMPLE WAS APPLIED. CALLER FURTHER REPORTED THE CUSTOMER SELF-INJECTED GLUCAGON. NO FURTHER INFORMATION WAS OBTAINED AS TROUBLESHOOTING WAS REFUSED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277705 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1450755

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention