BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 11825348 · Received May 14, 2021

    Report

    Report Number
    2954323-2021-69250
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    May 5, 2021
    Report Date
    July 14, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG IS FULLY SEATED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE 5 (INDICATING NORMAL TERMINATION). INSPECTED THE PLUG ASSEMBLY, NO ISSUES WERE OBSERVED. THE CURRENT WAS APPLIED TO THE SENSOR TO PERFORM LINEARITY TESTING WHILE IN THE TEST FIXTURE. ALL RESULTS WERE WITHIN SPECIFICATION. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS FOR THE FS LIBRE SENSOR AND FS LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FS LIBRE SENSOR AND SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    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. 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 SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A LOW READINGS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE 2 SENSOR. CUSTOMER REPORTED RECEIVING LOW SENSOR SCAN RESULTS, AND ALTHOUGH NO SYMPTOMS WERE EXPERIENCED, CUSTOMER SELF-PRESENTED TO A HOSPITAL WHERE A READING OF 1080 MG/DL WAS OBTAINED ON THE HOSPITAL METER COMPARED TO SENSOR SCAN RESULTS OF 100-117 MG/DL. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN VIA INTRAVENOUS INFUSION AND "AFTER 1 DAY" HIS BLOOD GLUCOSE LOWERED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A LOW READINGS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE 2 SENSOR. CUSTOMER REPORTED RECEIVING LOW SENSOR SCAN RESULTS, AND ALTHOUGH NO SYMPTOMS WERE EXPERIENCED, CUSTOMER SELF-PRESENTED TO A HOSPITAL WHERE A READING OF 1080 MG/DL WAS OBTAINED ON THE HOSPITAL METER COMPARED TO SENSOR SCAN RESULTS OF 100-117 MG/DL. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN VIA INTRAVENOUS INFUSION AND "AFTER 1 DAY" HIS BLOOD GLUCOSE LOWERED. 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

    A LOW READINGS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE 2 SENSOR. CUSTOMER REPORTED RECEIVING LOW SENSOR SCAN RESULTS, AND ALTHOUGH NO SYMPTOMS WERE EXPERIENCED, CUSTOMER SELF-PRESENTED TO A HOSPITAL WHERE A READING OF 1080 MG/DL WAS OBTAINED ON THE HOSPITAL METER COMPARED TO SENSOR SCAN RESULTS OF 100-117 MG/DL. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN VIA INTRAVENOUS INFUSION AND "AFTER 1 DAY" HIS BLOOD GLUCOSE LOWERED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723176 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R