BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 12044947 · Received June 22, 2021

    Report

    Report Number
    2954323-2021-73237
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. AN 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. A CLINICAL REVIEW HAS BEEN CONDUCTED AND THIS REVIEW HAS FOUND NO INDICATION OF ANY PRODUCT CLINICAL PERFORMANCE ISSUES. 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, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THE LITERATURE REVIEW REPORTED 15 USERS AND DEVICES. ALL SERIAL NUMBERS ARE UNKNOWN. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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

    ABBOTT DIABETES CARE BECAME AWARE OF AN ARTICLE BY M. KRAKAUER, ET AL TITLED, ¿A REVIEW OF FLASH GLUCOSE MONITORING IN TYPE 2 DIABETES", PUBLISHED IN BIOMED CENTRAL JOURNALS, VOLUME 13, NUMBER 42, 2021. THE RESULTS OF THE CLINICAL TRIAL CONCLUDED THAT TYPE 2 DIABETIC PATIENTS WHO USE FLASH GLUCOSE MONITORING MIGHT EXPECT TO ACHIEVE SIGNIFICANT IMPROVEMENT IN HBA1C AND GLYCEMIC PARAMETERS AND SEVERAL ASSOCIATED BENEFITS. OF THE PARTICIPANTS, NINE SENSOR ADHESIVE REACTIONS IN SIX PARTICIPANTS WERE DESCRIBED WITH INTENSITY REPORTED AS SEVERE (N = 2), MODERATE (N = 6), OR MILD (N = 1). SIXTEEN DEVICE-RELATED ADVERSE EVENTS (SENSOR ADHESIVE OR SITE REACTIONS) WERE REPORTED IN NINE PARTICIPANTS, WHICH WERE CLASSIFIED AS SEVERE (N = 4), MODERATE (N = 9) OR MILD (N = 3). ALL EVENTS RESOLVED AFTER TREATMENT WITH MAINLY TOPICAL PREPARATIONS (UNSPECIFIED). THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936253 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention