BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE PRECISION NEO

    MDR report key: 11293562 · Received February 8, 2021

    Report

    Report Number
    2954323-2021-03294
    Event Type
    Injury
    Date Received
    February 8, 2021
    Date of Event
    November 30, 2020
    Report Date
    April 9, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K140371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS FOR THE PRECISION STRIPS WERE REVIEWED AND THE DHRS SHOWED THE PRECISION STRIPS PASSED ALL TESTS PRIOR TO RELEASE. DHRS FOR THE FREESTYLE PRECISION NEO METER WAS REVIEWED AND THE DHRS SHOWED THE FREESTYLE PRECISION NEO METER PASSED ALL TESTS PRIOR TO RELEASE. STRIPS EXPIRED AS OF 31-JUL-2014. RETAIN TESTING APPLIES TO UNEXPIRED PRODUCT. RETAIN TESTING NOT APPLICABLE IN THIS CASE. 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 RECEIVING LOW READINGS FROM THE ADC GLUCOSE METER. THE CUSTOMER EXPERIENCED SYMPTOMS OF "NO TASTE", DISTORTED VISION, BECAME HYPOGLYCEMIC, AND SEIZURE. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND NO FURTHER INFORMATION WAS REPORTED. IT SHOULD BE NOTED THAT THE TEST STRIPS THAT CUSTOMER USED AT TIME OF EVENT WERE FOUND TO BE EXPIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    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. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IS PER THE CUSTOMER'S REPORT OF "END OF (B)(6)." ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING LOW READINGS FROM THE ADC GLUCOSE METER. THE CUSTOMER EXPERIENCED SYMPTOMS OF "NO TASTE", DISTORTED VISION, BECAME HYPOGLYCEMIC, AND SEIZURE. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND NO FURTHER INFORMATION WAS REPORTED. IT SHOULD BE NOTED THAT THE TEST STRIPS THAT CUSTOMER USED AT TIME OF EVENT WERE FOUND TO BE EXPIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191065 FREESTYLE PRECISION NEO BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 75175-84 4500161212

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR