BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 13795968 · Received March 17, 2022

    Report

    Report Number
    2954323-2022-08635
    Event Type
    Injury
    Date Received
    March 17, 2022
    Date of Event
    February 17, 2022
    Report Date
    May 11, 2022
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 FS LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FS LIBRE 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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72114-01 WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71992-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SENSOR (B)(6) WAS RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED ON THE RETURNED SENSOR PATCH AND NO ISSUES WERE OBSERVED. OBSERVED THE ADHESIVE WAS RETURNED. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72114-01 WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71992-01.

    Description of Event or Problem · 0

    AN ADHESIVE ISSUE WAS REPORTED WITH THE ADC DEVICE. THE SENSOR PREMATURELY DETACHED AFTER 3 DAYS OF WEAR AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS AND MONITOR GLUCOSE LEVELS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF BAQSIMI GLUCAGON NASAL POWDER ADMINISTERED BY THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    AN ADHESIVE ISSUE WAS REPORTED WITH THE ADC DEVICE. THE SENSOR PREMATURELY DETACHED AFTER 3 DAYS OF WEAR AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS AND MONITOR GLUCOSE LEVELS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF BAQSIMI GLUCAGON NASAL POWDER ADMINISTERED BY 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
    525683 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 72114-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention