BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 8621695 · Received May 17, 2019

    Report

    Report Number
    2954323-2019-04020
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    March 1, 2019
    Report Date
    February 21, 2020
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED AND 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 KIT WERE REVIEWED AND THE DHRS SHOWED THE 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.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED EXPERIENCING AN ADVERSE SKIN REACTION AFTER WEARING THE ADC FREESTYLE LIBRE FOR 14 DAYS, WITH SYMPTOMS OF REDNESS AND SKIN EROSION THAT OCCURRED IN "FEBRUARY". THE CUSTOMER FURTHER REPORTED HAVING HAD CONTACT WITH AN HCP IN "MARCH" WHO PRESCRIBED SODERM (BETAMETHASONE, A CORTICOSTEROID) CREAM FOR TREATMENT AND RECOMMENDED DISCONTINUATION OF SENSOR USE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT 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 EXACT DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IS BASED ON CUSTOMER'S REPORT OF "MARCH". THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EXPERIENCING AN ADVERSE SKIN REACTION AFTER WEARING THE ADC FREESTYLE LIBRE FOR 14 DAYS, WITH SYMPTOMS OF REDNESS AND SKIN EROSION THAT OCCURRED IN "FEBRUARY". THE CUSTOMER FURTHER REPORTED HAVING HAD CONTACT WITH AN HCP IN "MARCH" WHO PRESCRIBED SODERM (BETAMETHASONE, A CORTICOSTEROID) CREAM FOR TREATMENT AND RECOMMENDED DISCONTINUATION OF SENSOR USE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414982 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention