BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 16823495 · Received April 27, 2023

    Report

    Report Number
    2954323-2023-16059
    Event Type
    Injury
    Date Received
    April 27, 2023
    Date of Event
    March 31, 2023
    Report Date
    May 10, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    UDI-DI
    00357599001018
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    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. 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. THE DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR AND LIBRE SENSOR KITS WERE REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND LIBRE SENSOR KITS PASSED ALL TESTS PRIOR TO RELEASE. 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.

    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 MANUFACTURING DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 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 · 0

    A REPLACE SENSOR/SCAN AGAIN IN 10/UNSPECIFIED-2023-16059-1 ERROR MESSAGE WAS REPORTED WITH THE ADC DEVICE AND CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED DIZZINESS AND WAS UNABLE TO SELF-TREAT, REQUIRING HEALTHCARE PROFESSIONAL (HCP) ADMINISTRATION OF UNSPECIFIED MEDICATION FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A REPLACE SENSOR/SCAN AGAIN IN 10/UNSPECIFIED ERROR MESSAGE WAS REPORTED WITH THE ADC DEVICE AND CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED DIZZINESS AND WAS UNABLE TO SELF-TREAT, REQUIRING HEALTHCARE PROFESSIONAL (HCP) ADMINISTRATION OF UNSPECIFIED MEDICATION FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613085 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01 00357599001018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention