BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 13385975 · Received January 28, 2022

    Report

    Report Number
    2954323-2022-03247
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    September 1, 2021
    Report Date
    August 9, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS FOR THE LIBRE SENSOR AND LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND SENSOR KIT 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.

    Additional Manufacturer Narrative · 0

    SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG IS FULLY SEATED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE 5 (INDICATING NORMAL TERMINATION). INSPECTED THE PLUG ASSEMBLY, NO ISSUES WERE OBSERVED. THE CURRENT WAS APPLIED TO THE SENSOR TO PERFORM ACCURACY TESTING WHILE IN THE TEST FIXTURE. ALL RESULTS WERE WITHIN SPECIFICATION. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A HIGH READING ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE SENSOR. A CUSTOMER REPORTED RECEIVING HIGH SENSOR SCANS OF 5.7 MMO/L AND 8.1 MMO/L WHEN COMPARED TO CAPILLARY RESULTS OF 2.7 MMO/L AND 4.2 MMO/L OBTAINED ON COMPETITOR BRAND METER. THE CUSTOMER EXPERIENCED SYMPTOMS OF CONFUSION, DIZZINESS, AND LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROVIDER WHO OBTAINED A BLOOD GLUCOSE RESULT OF 2.7 MMO/L AND ADMINISTERED UNSPECIFIED TREATMENT FOR THE DIAGNOSIS OF HYPOGLYCEMIA. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A HIGH READING ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE SENSOR. A CUSTOMER REPORTED RECEIVING HIGH SENSOR SCANS OF 5.7 MMO/L AND 8.1 MMO/L WHEN COMPARED TO CAPILLARY RESULTS OF 2.7 MMO/L AND 4.2 MMO/L OBTAINED ON COMPETITOR BRAND METER. THE CUSTOMER EXPERIENCED SYMPTOMS OF CONFUSION, DIZZINESS, AND LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROVIDER WHO OBTAINED A BLOOD GLUCOSE RESULT OF 2.7 MMO/L AND ADMINISTERED UNSPECIFIED TREATMENT FOR THE DIAGNOSIS OF HYPOGLYCEMIA. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751569 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention