BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE PRECISION NEO

    MDR report key: 15249974 · Received August 18, 2022

    Report

    Report Number
    2954323-2022-29752
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K140371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT. THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS (DEVICE HISTORY RECORD) FOR THE FREESTYLE PRECISION NEO METER WERE REVIEWED, AND THE DHRS SHOWED THE FREESTYLE PRECISION NEO METER PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE ADC DEVICE ALWAYS HAS LOW BATTERY, EVEN AFTER CHARGING. THE CUSTOMER REPORTED THIS ISSUE RESULTED IN CUSTOMER BECOMING HYPOGLYCEMIC, WITH SWEATING, WEAKNESS, AND BLURRED VISION. THE CUSTOMER WAS TREATED WITH SUGAR-WATER BY A THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369360 FREESTYLE PRECISION NEO BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 75175-84

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention