BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 7150067 · Received December 27, 2017

    Report

    Report Number
    2954323-2017-09129
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    November 29, 2017
    Report Date
    April 12, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SENSOR (B)(4) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM RETURNED SENSOR USING APPROVED SOFTWARE. SENSOR FOUND TO BE IN STATE 5 (INDICATING NORMAL TERMINATION). OBSERVED SENSOR PLUG WAS PROPERLY SEATED IN MOUNT. REMOVED THE SENSOR PLUG ASSEMBLY AND PERFORMED VISUAL INSPECTION. EXTENDED INVESTIGATION HAS ALSO BEEN PERFORMED. DOSE AUDIT REPORTS AND ENVIRONMENTAL MONITORING REPORTS, INCLUDING BIOBURDEN AND ENDOTOXIN TESTING, WERE REVIEWED FOR THE QUARTERLY PERIOD DURING WHICH EACH COMPLAINT UNIT WAS MANUFACTURED. NO ABNORMALITIES WERE FOUND, AND THE INVESTIGATION SHOWED ALL PROCESSES WERE EFFECTIVE. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    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 DATE REPORTED 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

    AN ALLERGIC REACTION WAS REPORTED WITH USE OF AN ADC FREESTYLE LIBRE SENSOR. CUSTOMER, WHO IS ALSO A DOCTOR, REPORTED THAT AFTER 3 DAYS OF WEARING THE SENSOR, HE EXPERIENCED SYMPTOMS DESCRIBED AS REDNESS AND ITCHING. CUSTOMER SELF-TREATED WITH MONOVO (MOMETASONE) CREAM, A PRESCRIPTION GRADE CORTICOSTEROID. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    AN ALLERGIC REACTION WAS REPORTED WITH USE OF AN ADC FREESTYLE LIBRE SENSOR. CUSTOMER, WHO IS ALSO A DOCTOR, REPORTED THAT AFTER 3 DAYS OF WEARING THE SENSOR, HE EXPERIENCED SYMPTOMS DESCRIBED AS REDNESS AND ITCHING. CUSTOMER SELF-TREATED WITH MONOVO (MOMETASONE) CREAM, A PRESCRIPTION GRADE 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
    927901 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC. 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention