BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 8296715 · Received February 1, 2019

    Report

    Report Number
    2954323-2019-00962
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    January 14, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND 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. DOSE AUDIT AND ENVIRONMENTAL MONITORING REPORTS WERE REVIEWED FOR ISSUES RELATING TO STERILITY OF THE PRODUCT. THE SENSOR COMPONENT HAS NO IMPACT ON PRODUCT STERILITY AND THEREFORE, SENSOR COMPONENTS DHRS WERE NOT REVIEWED. SENSOR KIT DHRS HAVE BEEN REVIEWED TO ASSESS THE MANUFACTURING PROCESS, WHICH INCLUDES THE APPLICATION OF THE ADHESIVE TO THE PUCK. DHRS (DEVICE HISTORY REVIEW) FOR ALL FS LIBRE SENSOR KITS WITHIN EXPIRATION AT THE TIME OF COMPLAINT WERE REVIEWED, AND THE DHR REVIEW SHOWED THERE WERE NO DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS. DOSE AUDIT REPORTS WERE REVIEWED AND DEMONSTRATES THE CONTINUED EFFECTIVENESS OF THE ESTABLISHED STERILIZATION PROCESS FOR LIBRE SENSOR KITS. 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. CLINICAL DATA WAS REVIEWED AND CONFIRMED THAT LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. A TRIPPED TREND REVIEW WAS COMPLETED FOR THE REPORTED COMPLAINT AND FS LIBRE SENSORS, NO CONFIRMED COMPLAINTS WERE OBSERVED. THERE WERE NO ADVERSE TRENDS THAT INDICATE ANY POTENTIAL PRODUCT RELATED ISSUES. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED AND A PHYSICAL INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    ABBOTT DIABETES CARE RECEIVED A USER REPORT FROM BFARM WHICH REPORTED THE FOLLOWING INFORMATION: CUSTOMER EXPERIENCED AN INTENSE ITCHING UNDER THE SENSOR WITH SLIGHT REDNESS AND RASH AT THE INSERTION SITE WHILE WEARING AN ADC FREESTYLE LIBRE SENSOR. THE CUSTOMER WAS TREATED WITH CORTISONE CREAM AND VARIOUS BARRIERS BETWEEN SENSOR AND SKIN (SPRAY DRESSING, PLASTER, BLISTER PLASTER). NO FURTHER TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY 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 DATE OF EVENT IS UNKNOWN. THE DEVICE MFG DATE IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ABBOTT DIABETES CARE RECEIVED A USER REPORT FROM (B)(6) WHICH REPORTED THE FOLLOWING INFORMATION: CUSTOMER EXPERIENCED AN INTENSE ITCHING UNDER THE SENSOR WITH SLIGHT REDNESS AND RASH AT THE INSERTION SITE WHILE WEARING AN ADC FREESTYLE LIBRE SENSOR. THE CUSTOMER WAS TREATED WITH CORTISONE CREAM AND VARIOUS BARRIERS BETWEEN SENSOR AND SKIN (SPRAY DRESSING, PLASTER, BLISTER PLASTER). NO FURTHER TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90528 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention