BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 2855050 · Received December 3, 2012

    Report

    Report Number
    2954323-2012-06751
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 27, 2012
    Report Date
    October 5, 2012
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE RETURNED PRODUCT DETERMINED THE CAUSE TO BE ISOLATED TO THE CAPACITOR. 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. EVALUATION RESULT: THERE WAS NO ADVERSE EVENT REPORTED. THE DATE, IS THE DATE ADC CONFIRMED THE ISSUE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. (B)(4).

    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
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1