BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 8826496 · Received July 25, 2019

    Report

    Report Number
    2954323-2019-05683
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    May 26, 2019
    Report Date
    September 10, 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

    SINCE NO PRODUCT HAS BEEN RETURNED, EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE REPORTED COMPLAINT IS RELATED TO SKIN IRRITATION AND ALLERGIC REACTIONS TO THE PATCH ADHESIVE OF THE 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 COMPONENT DHRS (DEVICE HISTORY REVIEW) WERE NOT REVIEWED. SENSOR KIT DHRS HAVE BEEN REVIEWED TO ASSESS THE MANUFACTURING PROCESS, WHICH INCLUDES THE APPLICATION OF THE ADHESIVE TO THE PUCK. THE DHR FOR THE LIBRE SENSOR KIT WAS REVIEWED AND SHOWED THE LIBRE SENSORKIT PASSED ALL TESTS PRIOR TO RELEASE. DOSE AUDIT REPORTS WERE REVIEWED AND DEMONSTRATED 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. ALL REVIEW ACTIVITIES CONDUCTED ABOVE, INCLUDING BUT NOT LIMITED TO THE FINAL RELEASE TESTING SPECIFICALLY ASSOCIATED WITH THE MANUFACTURE OF THIS PRODUCT, ARE SUFFICIENT INFORMATION IN ORDER TO SHOW IF THE PRODUCT HAS MET SPECIFICATIONS PRIOR TO RELEASE. 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: A CUSTOMER, WHO IS A PHARMACIST, REPORTED EXPERIENCING A CONTACT ALLERGY WHILE WEARING ADC FREESTYLE LIBRE SENSORS, AFTER SEVERAL MONTHS OF USE. THE CUSTOMER WAS CONTACTED IN FOLLOW-UP AND REPORTED THAT ON MAY 26, 2019 HE SELF-TREATED WITH AN UNSPECIFIED HYDROCORTISONE CREAM. HE ALSO NOW USES HANSA BLISTER PLASTER UNDERNEATH THE SENSOR AND IS NO LONGER HAVING SKIN ISSUES. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED. A FOLLOW-UP REPORT WILL BE FILED IF PRODUCT IS RETURNED OR ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF MANUFACTURE IS UNKNOWN. THE DATE LISTED IS THE DATE WHEN 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

    ABBOTT DIABETES CARE RECEIVED A USER REPORT FROM BFARM WHICH REPORTED THE FOLLOWING INFORMATION: A CUSTOMER, WHO IS A PHARMACIST, REPORTED EXPERIENCING A CONTACT ALLERGY WHILE WEARING ADC FREESTYLE LIBRE SENSORS, AFTER SEVERAL MONTHS OF USE. THE CUSTOMER WAS CONTACTED IN FOLLOW-UP AND REPORTED THAT ON (B)(6) 2019 HE SELF-TREATED WITH AN UNSPECIFIED HYDROCORTISONE CREAM. HE ALSO NOW USES HANSA BLISTER PLASTER UNDERNEATH THE SENSOR AND IS NO LONGER HAVING SKIN ISSUES. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622327 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention