BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 15048258 · Received July 18, 2022

    Report

    Report Number
    2954323-2022-24594
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    July 9, 2022
    Report Date
    December 15, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT, AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS (DEVICE HISTORY RECORD) FOR THE FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE SENSOR KIT WERE REVIEWED, AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR AND SENSOR KIT 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

    SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG IS FULLY SEATED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE 6 (INDICATING EARLY TERMINATION). INSPECTED THE PLUG ASSEMBLY. THE CURRENT WAS APPLIED TO THE SENSOR TO PERFORM ACCURACY TESTING WHILE IN THE TEST FIXTURE. ALL RESULTS WERE WITHIN SPECIFICATION. POISE VOLTAGE AND SENSOR THERMISTOR TESTING WERE BOTH WITHIN SPECIFICATION, INDICATING THE SENSOR WAS PROVIDING ACCURATE GLUCOSE READINGS. ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CAREGIVER (PARENT) REPORTED A HIGH READING ISSUE WITH THE ADC DEVICE. THE CAREGIVER REPORTED HIGH SENSOR READINGS AS COMPARED TO THE READER'S BUILT-IN METER, AND AS A RESULT, THE CUSTOMER REQUIRED TREATMENT OF CANDY FOR HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT. A READINGS COMPARISON OF 20.8 MMOL/L, 'HI' (> 27.8 MMOL/L), AND 'HI' (> 27.8 MMOL/L) FROM SENSOR AGAINST 3.0 MMOL/L, 3.0 MMOL/L, AND 3.8 MMOL/L FROM BUILT-IN METER WAS PROVIDED. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FALL INTO THE "D" ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT.

    Description of Event or Problem · 0

    A CAREGIVER (PARENT) REPORTED A HIGH READING ISSUE WITH THE ADC DEVICE. THE CAREGIVER REPORTED HIGH SENSOR READINGS AS COMPARED TO THE READER'S BUILT-IN METER, AND AS A RESULT, THE CUSTOMER REQUIRED TREATMENT OF CANDY FOR HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT. A READINGS COMPARISON OF 20.8 MMOL/L, 'HI' (> 27.8 MMOL/L), AND 'HI' (> 27.8 MMOL/L) FROM SENSOR AGAINST 3.0 MMOL/L, 3.0 MMOL/L, AND 3.8 MMOL/L FROM BUILT-IN METER WAS PROVIDED. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FALL INTO THE "D" ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653425 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention