BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 12193546 · Received July 19, 2021

    Report

    Report Number
    2954323-2021-76549
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    June 19, 2021
    Report Date
    July 27, 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

    PRODUCT HAS NOT YET BEEN RETURNED FOR THIS COMPLAINT. ADC INVESTIGATED THE COMPLAINT FOR LOW READINGS OF THE SENSOR SCAN AND DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. SENSOR KIT EXPIRATION DATE WAS DETERMINED TO BE 31-OCT-20. MEDICAL EVENT WAS OCCURED ON 19-JUN-21, WHICH CONFIRMS THE USAGE BEYOND THE USEFUL LIFE OF THE DEVICE. ADDITIONAL INVESTIGATION ACTIVITIES ARE NOT REQUIRED AT THIS TIME AS THE DEVICE MET SPECIFICATION WHEN IT WAS RELEASED AND THROUGHOUT ITS LIFESPAN. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED, AND A PHYSICAL INVESTIGATION WILL BE PERFORMED. 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 (A CHILD OF 13 YEARS) WAS AT A HEALTH CLINIC AND OBTAINED A SENSOR SCAN RESULT OF 55 MG/DL. APPLE JUICE WAS PROVIDED TO THE CUSTOMER IN RESPONSE TO THE READING AND WITHIN 15 MINUTES, CUSTOMER EXPERIENCED DIZZINESS AND A READING OF 339 MG/DL WAS OBTAINED ON THE HCP METER. CUSTOMER WAS ADMINISTERED 10 UNITS OF NOVORAPID INSULIN AND NO FURTHER TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED AS REPORTER INDICATED THE DEVICE WAS DISCARDED. IN THE EVENT THAT UNANTICIPATED PRODUCT IS RECEIVED, A PHYSICAL INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. 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 (A CHILD OF (B)(6)) WAS AT A HEALTH CLINIC AND OBTAINED A SENSOR SCAN RESULT OF 55 MG/DL. APPLE JUICE WAS PROVIDED TO THE CUSTOMER IN RESPONSE TO THE READING AND WITHIN 15 MINUTES, CUSTOMER EXPERIENCED DIZZINESS AND A READING OF 339 MG/DL WAS OBTAINED ON THE HCP METER. CUSTOMER WAS ADMINISTERED 10 UNITS OF NOVORAPID INSULIN AND NO FURTHER TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084243 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention