BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 16302153 · Received February 5, 2023

    Report

    Report Number
    2954323-2023-05472
    Event Type
    Injury
    Date Received
    February 5, 2023
    Date of Event
    January 11, 2023
    Report Date
    May 16, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT 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. 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. UPON EXTENDED INVESTIGATION, IT WAS DETERMINED THAT THE SERIAL NUMBER PROVIDED BY THE CUSTOMER (B)(6) AND PREVIOUSLY REPORTED TO THE FDA WAS NOT A VALID SERIAL NUMBER. THEREFORE, SECTION D4 WAS UPDATED TO UNK.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING A ¿SENSOR ENDED¿ ERROR MESSAGE WITH THE ADC DEVICE AND AS A RESULT, THE CUSTOMER WAS UNABLE TO OBTAIN SENSOR READINGS. THE CUSTOMER EXPERIENCED DESCRIBED AS "BLACKOUT" AND DIZZINESS AND WAS PROVIDED WATER BY THEIR SPOUSE AND HI-C FRUIT JUICE BY A HEALTHCARE PROFESSIONAL. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING A ¿SENSOR ENDED¿ ERROR MESSAGE WITH THE ADC DEVICE AND AS A RESULT, THE CUSTOMER WAS UNABLE TO OBTAIN SENSOR READINGS. THE CUSTOMER EXPERIENCED DESCRIBED AS "BLACKOUT" AND DIZZINESS AND WAS PROVIDED WATER BY THEIR SPOUSE AND HI-C FRUIT JUICE BY A HEALTHCARE PROFESSIONAL. 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
    1327010 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention