BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 3972141 · Received July 31, 2014

    Report

    Report Number
    2954323-2014-00829
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE RETURNED PRODUCT DETERMINED THE CAUSE TO BE ISOLATED TO SOFTWARE CORRUPTION. ALTHOUGH GLUCOSE RESULTS MAY BE DELAYED, BLOOD GLUCOSE COULD BE DETERMINED BY ALTERNATE MEANS, INCLUDING USE OF ANOTHER BLOOD GLUCOSE METER, SEEING A PHYSICIAN (AS RECOMMENDED IN PRODUCT LABELING), OR BY SEEKING TREATMENT AT A HEALTH CARE FACILITY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTED THAT THEIR ADC METER DID NOT TURN ON. THE PRODUCT WAS RETURNED AND INVESTIGATED. THIS MDR IS BEING SUBMITTED DUE TO RETURNED PRODUCT INVESTIGATION RESULTS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447940 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1