BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 7140313 · Received December 21, 2017

    Report

    Report Number
    2954323-2017-09034
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    November 28, 2017
    Report Date
    March 7, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED FOR RETURN. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF EVENT IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED AND THE REPORTED SENSOR SERIAL NUMBER IS DEEMED TO BE INVALID. 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 WITHIN EXPIRATION AT THE TIME OF COMPLAINT WERE REVIEWED AND THE DHR REVIEW SHOWED NO THERE WERE NO DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS AND NO ISSUES IDENTIFIED THAT COULD HAVE LED TO THE COMPLAINT 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 TRIPS WERE OBSERVED. 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EXPERIENCING AN ALLERGIC REACTION WHEN WEARING A FREESTYLE LIBRE SENSOR. THE CUSTOMER INDICATED THAT SHE EXPERIENCED ITCHING AND HAD CONTACT WITH A HEALTHCARE PROVIDER WHO PRESCRIBED AN UNSPECIFIED CREAM TO APPLY TO THE SKIN PRIOR TO APPLYING A SENSOR. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EXPERIENCING AN ALLERGIC REACTION WHEN WEARING A FREESTYLE LIBRE SENSOR. THE CUSTOMER INDICATED THAT SHE EXPERIENCED ITCHING AND HAD CONTACT WITH A HEALTHCARE PROVIDER WHO PRESCRIBED AN UNSPECIFIED CREAM TO APPLY TO THE SKIN PRIOR TO APPLYING A SENSOR. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917652 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC. 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention