BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 11823098 · Received May 13, 2021

    Report

    Report Number
    2954323-2021-69204
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    December 31, 2020
    Report Date
    May 13, 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 · 1

    ABBOTT DIABETES CARE PRODUCT QUALITY ENGINEERING (PQE) INVESTIGATED THE ALARM-3 (MISSING HIGH OR LOW GLUCOSE ) COMPLAINT. THE SERIAL NUMBER OF THE FREESTYLE LIBRE 2 SENSOR ASSOCIATED WITH THIS COMPLAINT IS UNKNOWN. DURING INVESTIGATION OF THE TRACK AND TREND REVIEW RELATED TO ALARM-3 CASES IN (B)(6) 2020, THIS FAILURE MODE WAS IDENTIFIED AND IS A KNOWN MANUFACTURING ISSUE THAT IMPACTS LIBRE 2 SENSORS MANUFACTURED AT (B)(4). AS THE SERIAL NUMBER OF THE SENSOR ASSOCIATED WITH THIS COMPLAINT IS UNKNOWN, PQE IS UNABLE TO DETERMINE IF THE SENSOR IS IMPACTED BY THIS MANUFACTURING ISSUE. OUTSIDE OF THE KNOWN MANUFACTURING ISSUE, THE AVAILABLE TRIPPED TREND REPORTS FOR LIBRE 2 SENSOR AND ALARM- 3 HAVE BEEN REVIEWED. THE REVIEW DID NOT IDENTIFY ANY ADDITIONAL TRENDS THAT WOULD INDICATE A PRODUCT RELATED ISSUE RELATED TO THIS COMPLAINT. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THE DEVICE MANUFACTURING 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 CUSTOMER REPORTED THAT THE LOW GLUCOSE ALARM DID NOT SOUND WITH THE FREESTYLE LIBRE 2 SENSOR. THE CUSTOMER REPORTED EXPERIENCING HYPOGLYCEMIC SEIZURE, BUT NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716202 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR