BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 17437114 · Received August 1, 2023

    Report

    Report Number
    2954323-2023-33051
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    July 21, 2023
    Report Date
    August 10, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. AT THIS TIME PRODUCT HAS NOT YET 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 FREESTYLE LIBRE READER WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE READER 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.THIS SERVES AS A CORRECTION REPORT. SECTION(S) UPDATED AS FOLLOWS: B1: UPDATED TO ADVERSE EVENT FROM PRODUCT PROBLEM

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. AT THIS TIME PRODUCT HAS NOT YET 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 FREESTYLE LIBRE READER WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE READER 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.

    Description of Event or Problem · 0

    A BUTTON/POWER ISSUE WAS REPORTED WITH THE ADC DEVICE. THE METER WOULD NOT POWER ON WITH A BUTTON PRESS, AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "HIGH-GLUCOSE AND HIGH KETO." IT WAS REPORTED THAT THE PARAMEDICS OBTAINED BLOOD GLUCOSE READINGS OF 481 AND 267 AT THE LABORATORY. AS A RESULT, THE CUSTOMER WAS ADMINISTERED (B)(4). UNITS OF INSULIN, 1 SODIUM GLORIDE (1 LR- INTRAVENOUSLY) AND 40 MEQ CALCIUM". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A BUTTON/POWER ISSUE WAS REPORTED WITH THE ADC DEVICE. THE METER WOULD NOT POWER ON WITH A BUTTON PRESS, AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "HIGH-GLUCOSE AND HIGH KETO." IT WAS REPORTED THAT THE PARAMEDICS OBTAINED BLOOD GLUCOSE READINGS OF 481 AND 267 AT THE LABORATORY. AS A RESULT, THE CUSTOMER WAS ADMINISTERED "20 UNITS OF INSULIN, 1 SODIUM GLORIDE (1 LR- INTRAVENOUSLY) AND 40 MEQ CALCIUM". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344703 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71953-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention