BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 6273770 · Received January 24, 2017

    Report

    Report Number
    2954323-2017-00673
    Event Type
    Malfunction
    Date Received
    January 24, 2017
    Date of Event
    January 3, 2017
    Report Date
    May 30, 2017
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNLESS FURTHER INFORMATION IS OBTAINED, THIS ISSUE IS CONSIDERED CLOSED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE RETURNED PRODUCT DETERMINED THE CAUSE TO BE ISOLATED TO THE MICROPROCESSOR/MICROCONTROLLER/PROCESSOR. 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.

    Additional Manufacturer Narrative · 1

    THIS SERVES AS A CORRECTION REPORT. BRAND NAME WAS INCORRECTLY IDENTIFIED AS FREESTYLE FREEDOM LITE. THE CORRECT BRAND NAME FOR THE REPORTED METER SERIAL NUMBER IS (B)(4). BRAND NAME HAS BEEN UPDATED TO REFLECT THE CORRECTION. IN ADDITION PMA/510K# HAS BEEN UPDATED TO K092602 AND CATALOG NO HAS BEEN UPDATED TO 71501-01.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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
    55542 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 71501-01

    Patients

    Seq Age Sex Outcome Treatment
    1