BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 9014071 · Received September 12, 2019

    Report

    Report Number
    2954323-2019-07062
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    August 12, 2019
    Report Date
    January 22, 2020
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. 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 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. CLINICAL DATA WAS REVIEWED AND CONFIRMED THAT FREESTYLE LIBRE SENSOR 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, AND THERE WERE NO ADVERSE TRENDS THAT INDICATE ANY POTENTIAL PRODUCT RELATED ISSUES. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED AND A PHYSICAL INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED EXPERIENCING AN ADVERSE SKIN REACTION WHILE WEARING AN ADC FREESTYLE LIBRE SENSOR FOR 4 DAYS. CUSTOMER FURTHER REPORTED EXPERIENCING SYMPTOMS PUS AND BLISTERING, AND HAVING CONTACT WITH A HEALTHCARE PROFESSIONAL ON (B)(6) 2019 WHO PRESCRIBED CLINIDERM PLASTER AND HYDROCORTISONE OINTMENT FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EXPERIENCING AN ADVERSE SKIN REACTION WHILE WEARING AN ADC FREESTYLE LIBRE SENSOR FOR 4 DAYS. CUSTOMER FURTHER REPORTED EXPERIENCING SYMPTOMS PUS AND BLISTERING, AND HAVING CONTACT WITH A HEALTHCARE PROFESSIONAL ON (B)(6) 2019 WHO PRESCRIBED CLINIDERM PLASTER AND HYDROCORTISONE OINTMENT FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797358 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention