BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE14 DAY

    MDR report key: 8505615 · Received April 11, 2019

    Report

    Report Number
    2954323-2019-02940
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    March 16, 2019
    Report Date
    October 3, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    NURSE

    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 DEVICE MFG DATE 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

    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 SENSOR KIT 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 · 1

    CAREGIVER (ALSO A NURSE) REPORTED ABOUT THE CUSTOMER WHO EXPERIENCED PAIN AND AN ALLERGIC SKIN REACTION ON DAY 10 OF WEAR OF THE ADC FREESTYLE LIBRE SENSOR. FURTHERMORE, THE CUSTOMER'S SYMPTOMS WERE DESCRIBED AS REDNESS, ITCHING, IRRITATION, PEELED SKIN AT THE SENSOR SITE. THE CUSTOMER WAS TREATED WITH BUDESONIDE (CORTICOSTEROID) SPRAY AND MENADERM SIMPLE (BECLOMETASONE - CORTICOSTEROID) BY THE NURSE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    CAREGIVER (ALSO A NURSE) REPORTED ABOUT THE CUSTOMER WHO EXPERIENCED PAIN AND AN ALLERGIC SKIN REACTION ON DAY 10 OF WEAR OF THE ADC FREESTYLE LIBRE SENSOR. FURTHERMORE, THE CUSTOMER'S SYMPTOMS WERE DESCRIBED AS REDNESS, ITCHING, IRRITATION, PEELED SKIN AT THE SENSOR SITE. THE CUSTOMER WAS TREATED WITH BUDESONIDE (CORTICOSTEROID) SPRAY AND MENADERM SIMPLE (BECLOMETASONE - CORTICOSTEROID) BY THE NURSE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299247 FREESTYLE LIBRE14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention