BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 7144673 · Received December 22, 2017

    Report

    Report Number
    2954323-2017-09056
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 28, 2017
    Report Date
    March 22, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS (DEVICE HISTORY REVIEW) FOR ALL FS LIBRE SENSORS AND FS LIBRE SENSOR KITS WITHIN EXPIRATION AT THE TIME OF COMPLAINT HAS BEEN REVIEWED AND THE DHR REVIEW SHOWED 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 AND NO TRIPPED TRENDS WERE OBSERVED. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED AND A PHYSICAL INVESTIGATION WILL BE PERFORMED.

    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 WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. THE DATE LISTED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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.

    Description of Event or Problem · 1

    CUSTOMER¿S FATHER, WHO IS ALSO A PHYSICIAN, REPORTED CUSTOMER EXPERIENCED AN INFECTION WHILE WEARING AN ADC FREESTYLE LIBRE SENSOR. IT WAS FURTHER REPORTED THE SKIN IRRITATION HAS HAPPENED TWICE. THE FIRST TIME THE SKIN WAS ¿IRRITATED WITH REDNESS¿, BUT THIS RESOLVED WITHOUT INTERVENTION. THE SECOND TIME THE IRRITATION APPEARED THERE WAS ¿REDNESS AND IT WAS PAINFUL¿. CALLER NOTED CUSTOMER HAD CONTACT WITH HIS HEALTHCARE PROVIDER, WAS DIAGNOSED WITH CELLULITIS AND PRESCRIBED UNSPECIFIED ANTIBIOTICS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER¿S FATHER, WHO IS ALSO A PHYSICIAN, REPORTED CUSTOMER EXPERIENCED AN INFECTION WHILE WEARING AN ADC FREESTYLE LIBRE SENSOR. IT WAS FURTHER REPORTED THE SKIN IRRITATION HAS HAPPENED TWICE. THE FIRST TIME THE SKIN WAS ¿IRRITATED WITH REDNESS¿, BUT THIS RESOLVED WITHOUT INTERVENTION. THE SECOND TIME THE IRRITATION APPEARED THERE WAS ¿REDNESS AND IT WAS PAINFUL¿. CALLER NOTED CUSTOMER HAD CONTACT WITH HIS HEALTHCARE PROVIDER, WAS DIAGNOSED WITH CELLULITIS AND PRESCRIBED UNSPECIFIED ANTIBIOTICS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920850 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC. 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention