BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3841623 · Received May 30, 2014

    Report

    Report Number
    2954323-2014-00608
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    November 19, 2015
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "PRODUCT PROBLEM" OF THE INITIAL MDR WAS LEFT UNCHECKED. THIS REPORT IS BEING UPDATED AS PART OF A RETROSPECTIVE REVIEW OF ISSUES RELATED TO THE REPORTABLE CONFIRMED MALFUNCTION LIST. THIS SECTION HAS BEEN UPDATED TO REFLECT THE CORRECTION.

    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. NOTE: THE ACTUAL DATE OF THE REPORTED MEDICAL EVENT IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE WAS UNABLE TO TEST DUE TO HER ADC BLOOD GLUCOSE METER NOT POWERING ON WITH BUTTON PRESS OR TEST STRIP INSERTION. CUSTOMER FURTHER REPORTED THAT WHILE ASLEEP IN BED, SHE "STARTED TO HAVE SEIZURES DUE TO (HER) SEVERE HYPOGLYCEMIC UNAWARENESS" AND STATED HER HUSBAND INJECTED HER WITH "AN ENTIRE DOSAGE OF GLUCAGON". CUSTOMER DID NOT SEEK ADDITIONAL THIRD-PARTY MEDICAL INTERVENTION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318051 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. 1370670

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R