BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 15653240 · Received October 21, 2022

    Report

    Report Number
    2954323-2022-38982
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    August 20, 2022
    Report Date
    January 31, 2023
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. IT IS UNKNOWN IF THE USER WAS USING ANDROID, IOS, OR A READER WITH THE FS LIBRE 3 SENSOR. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. 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. CLINICAL DATA WAS REVIEWED AND CONFIRMED THAT LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA FOR LIBRE SENSORS WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD HAVE LEAD TO THE COMPLAINT. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND FS LIBRE SENSORS, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW UP REPORT WILL BE SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A LOW READING ISSUE WITH THE ADC DEVICE. THE CUSTOMER OBTAINED AN UNSPECIFIED LOW READING AND FELT DIZZY AND TIRED. THE CUSTOMER WAS SEEN BY A HEALTHCARE PROFESSIONAL WHO OBTAINED A GLUCOSE RESULT OF 22 MMOL/L (396 MG/DL) AND WAS PROVIDED UNSPECIFIED TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT. ADDITIONALLY, A SENSOR READING OF 7.8 MMOL/L WAS COMPARED AGAINST HCP METER READING OF 22 MMOL/L AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FELL INTO THE 'C' ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED A LOW READING ISSUE WITH THE ADC DEVICE. THE CUSTOMER OBTAINED AN UNSPECIFIED LOW READING AND FELT DIZZY AND TIRED. THE CUSTOMER WAS SEEN BY A HEALTHCARE PROFESSIONAL WHO OBTAINED A GLUCOSE RESULT OF 22 MMOL/L (396 MG/DL) AND WAS PROVIDED UNSPECIFIED TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT. ADDITIONALLY, A SENSOR READING OF 7.8 MMOL/L WAS COMPARED AGAINST HCP METER READING OF 22 MMOL/L AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FELL INTO THE 'C' ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928111 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 72081-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention