BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 9608018 · Received January 20, 2020

    Report

    Report Number
    2954323-2020-00588
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    November 25, 2019
    Report Date
    April 2, 2020
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION HAS BEEN PERFORMED ON THE RETURNED SENSOR PATCH (SERIAL NUMBER (B)(6)) AND NO ISSUES WERE OBSERVED. OBSERVED THE ADHESIVE WAS RETURNED. EXTENDED INVESTIGATION HAS ALSO BEEN PERFORMED. A DHR (DEVICE HISTORY REVIEW) WAS REVIEWED AND VERIFIED THAT THE UNIT PASSED ALL TESTS PRIOR TO RELEASE. DOSE AUDIT REPORTS AND ENVIRONMENTAL MONITORING REPORTS, INCLUDING BIOBURDEN AND ENDOTOXIN TESTING, WERE REVIEWED AND DEMONSTRATED THAT ALL MONITORING PROCESSES CONTINUE TO MEET REQUIREMENTS. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A SKIN REACTION WITH THE USE OF THE ADC FREESTYLE LIBRE SENSOR AND EXPERIENCED "ITCHING UNDER THE SENSOR AND BURNING - SWELTERING ON THE SKIN". CUSTOMER HAD CONTACT WITH AN HCP WHO PRESCRIBED HIM A NASAL SPRAY, MEMETASONE FUROATE SANDOZ (50 MG), FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    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.   THE REPORTED COMPLAINT IS RELATED TO SKIN IRRITATION OR AN ALLERGIC REACTION TO THE PATCH ADHESIVE OF THE FREESTYLE LIBRE SENSOR.   DHRS (DEVICE HISTORY REVIEW) FOR THE FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE.   DOSE AUDIT REPORTS WERE REVIEWED AND DEMONSTRATES THE CONTINUED EFFECTIVENESS OF THE ESTABLISHED STERILIZATION PROCESS FOR LIBRE SENSOR PRODUCTS. ENVIRONMENTAL MONITORING REPORTS WERE REVIEWED, INCLUDING BIOBURDEN AND ENDOTOXIN TESTING, AND DEMONSTRATED THAT ALL MONITORING PROCESSES CONTINUE TO MEET ADC MINIMUM REQUIREMENTS FOR PRODUCT QUALITY.     IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED AND A PHYSICAL INVESTIGATION WILL BE PERFORMED.   ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SKIN REACTION WITH THE USE OF THE ADC FREESTYLE LIBRE SENSOR AND EXPERIENCED "ITCHING UNDER THE SENSOR AND BURNING - SWELTERING ON THE SKIN". CUSTOMER HAD CONTACT WITH AN HCP WHO PRESCRIBED HIM A NASAL SPRAY, MOMETASONE FUROATE SANDOZ (50 MG), FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70622 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention