BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 7133824 · Received December 20, 2017

    Report

    Report Number
    2954323-2017-08974
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    August 1, 2017
    Report Date
    March 7, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    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 AN APPROXIMATION BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. THE DEVICE MANUFACTURER DATE FOR THE REPORTED SENSOR 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.

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED. 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. A DHR (DEVICE HISTORY REVIEW) FOR THE FREESTYLE LIBRE SENSOR KIT WAS REVIEWED AND THE DHR 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 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 THAT 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. THIS ALSO SERVES AS A CORRECTION REPORT. SECTIONS (ADVERSE EVENT/PRODUCT PROBLEM) AND (OUTCOMES ATTRIBUTED TO AE) WERE INCORRECTLY DOCUMENTED IN THE INITIAL MDR 30 DAY REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EXPERIENCING SKIN IRRITATION RELATED TO THE USE OF A FREESTYLE LIBRE SENSOR. THE CUSTOMER REPORTED THAT AFTER 5 DAYS THEY EXPERIENCED ITCHING, RED SKIN, BLISTERING. THE CUSTOMER REPORTED HAVING CONTACT WITH A HEALTH CARE PROVIDER IN (B)(6) 2017 (DATE WAS NOT SPECIFIED) AND BEING PRESCRIBED A CORTISONE OINTMENT AND BEING DIAGNOSED WITH ALLERGIC SKIN REACTION. THE CUSTOMER INDICATED THAT AFTER REMOVING THE SENSOR AND APPLYING THE CORTISONE OINTMENT THE AREA WAS "OK." NO ADDITIONAL TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT AS A RESULT OF THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EXPERIENCING SKIN IRRITATION RELATED TO THE USE OF A FREESTYLE LIBRE SENSOR. THE CUSTOMER REPORTED THAT AFTER 5 DAYS THEY EXPERIENCED ITCHING, RED SKIN, BLISTERING. THE CUSTOMER REPORTED HAVING CONTACT WITH A HEALTH CARE PROVIDER IN (B)(6) 2017 (DATE WAS NOT SPECIFIED) AND BEING PRESCRIBED A CORTISONE OINTMENT AND BEING DIAGNOSED WITH ALLERGIC SKIN REACTION. THE CUSTOMER INDICATED THAT AFTER REMOVING THE SENSOR AND APPLYING THE CORTISONE OINTMENT THE AREA WAS "OK." NO ADDITIONAL TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913822 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC. 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention