BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 13771052 · Received March 15, 2022

    Report

    Report Number
    2954323-2022-08460
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    February 18, 2022
    Report Date
    March 15, 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 IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS (DEVICE HISTORY RECORD) FOR THE LIBRE SENSOR AND LIBRE SENSOR KITS WERE REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND LIBRE SENSOR KITS 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.

    Description of Event or Problem · 0

    AN ALARM ISSUE WAS REPORTED WITH THE ADC DEVICE. THE CUSTOMER INDICATED THAT THE LOW GLUCOSE ALARM DID NOT SOUND WHEN THEY BECAME HYPOGLYCEMIC AND EXPERIENCED SEIZURE AND LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS TRANSPORTED TO THE HOSPITAL WHERE THEY RECEIVED GLUCOSE DRIP FOR TREATMENT OF HYPOGLYCEMIA AND PAINKILLERS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696519 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 72114-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention