BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 7123820 · Received December 15, 2017

    Report

    Report Number
    2954323-2017-08857
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 13, 2017
    Report Date
    January 15, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE METER 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.

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT 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. THE DOSE AUDIT REPORT COVERS THE REQUIRED TIME PERIOD. 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 · 1

    CUSTOMER REPORTED EXPERIENCING AN ALLERGIC SKIN REACTION WHILE WEARING AN ADC FREESTYLE LIBRE SENSOR. IT WAS FURTHER REPORTED THE REACTIONS HAVE BEEN OCCURRING WITH EVERY SENSOR SINCE (B)(6) 2017. CUSTOMER NOTED THE SKIN WHERE THE SENSOR WAS APPLIED WAS RED AND SHE THOUGHT THERE WAS AN INFECTION. CUSTOMER REPORTED HAVING CONTACT WITH A HEALTHCARE PROFESSIONAL ON (B)(6) 2017 AND WAS PRESCRIBED BETAMETHASONE, (A CORTICOSTEROID). THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EXPERIENCING AN ALLERGIC SKIN REACTION WHILE WEARING AN ADC FREESTYLE LIBRE SENSOR. IT WAS FURTHER REPORTED THE REACTIONS HAVE BEEN OCCURRING WITH EVERY SENSOR SINCE (B)(6) 2017. CUSTOMER NOTED THE SKIN WHERE THE SENSOR WAS APPLIED WAS RED AND SHE THOUGHT THERE WAS AN INFECTION. CUSTOMER REPORTED HAVING CONTACT WITH A HEALTHCARE PROFESSIONAL ON (B)(6) 2017 AND WAS PRESCRIBED BETAMETHASONE, (A CORTICOSTEROID). THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903363 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC. 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention