BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 12355536 · Received August 23, 2021

    Report

    Report Number
    2954323-2021-81245
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    July 17, 2021
    Report Date
    January 3, 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
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SENSOR 0M0065UF6RM 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 1(INDICATING THE SENSOR WAS NEVER ACTIVATED BY THE CUSTOMER). VISUAL INSPECTION WAS PERFORMED ON THE SENSOR PLUG AND DAMAGED WERE OBSERVED TO THE SENSOR EAR. THE PLUG WAS SEATED CORRECTLY AND THEREFORE THE DAMAGED SENSOR EARS DID NOT CAUSE THE CUSTOMER COMPLAINT. THEREFORE, THE ISSUE IS NOT CONFIRMED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS FOR THE FS LIBRE SENSOR AND FS LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FS LIBRE SENSOR AND SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND 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. STABILITY DATA FOR LIBRE SENSORS WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD HAVE LEAD TO THE COMPLAINT. 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.

    Description of Event or Problem · 0

    A LOW READINGS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE SENSOR. CUSTOMER REPORTED RECEIVING SENSOR SCAN RESULTS THAT "VARIED FROM 4 TO 10 MMOL/L" AND EXPERIENCING SYMPTOMS DESCRIBED AS VOMITING, DIARRHEA, AND LETHARGY. CUSTOMER WAS SEEN AT A HOSPITAL WHERE A READING OF 'HI' WAS OBTAINED ON THE HCP DEVICE AND CUSTOMER WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND TREATED WITH "LIQUIDS AND INSULIN" (DOSE/TYPE UNSPECIFIED). SENSOR READINGS OF 4 MMOL/L AND 10 MMO/L WERE PLOTTED ON A PARKES ERROR GRID COMPARED TO 27.8 MMOL/L (HI) AND FELL INTO THE "D" AND "C" ZONES RESPECTIVELY, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A LOW READINGS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE SENSOR. CUSTOMER REPORTED RECEIVING SENSOR SCAN RESULTS THAT "VARIED FROM 4 TO 10 MMOL/L" AND EXPERIENCING SYMPTOMS DESCRIBED AS VOMITING, DIARRHEA, AND LETHARGY. CUSTOMER WAS SEEN AT A HOSPITAL WHERE A READING OF 'HI' WAS OBTAINED ON THE HCP DEVICE AND CUSTOMER WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND TREATED WITH "LIQUIDS AND INSULIN" (DOSE/TYPE UNSPECIFIED). SENSOR READINGS OF 4 MMOL/L AND 10 MMO/L WERE PLOTTED ON A PARKES ERROR GRID COMPARED TO 27.8 MMOL/L (HI) AND FELL INTO THE "D" AND "C" ZONES RESPECTIVELY, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED AS THE DEVICE WAS REPORTEDLY DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF PRODUCT IS RETURNED OR 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.

    Description of Event or Problem · 1

    A LOW READINGS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE SENSOR. CUSTOMER REPORTED RECEIVING SENSOR SCAN RESULTS THAT "VARIED FROM 4 TO 10 MMOL/L" AND EXPERIENCING SYMPTOMS DESCRIBED AS VOMITING, DIARRHEA, AND LETHARGY. CUSTOMER WAS SEEN AT A HOSPITAL WHERE A READING OF 'HI' WAS OBTAINED ON THE HCP DEVICE AND CUSTOMER WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND TREATED WITH "LIQUIDS AND INSULIN" (DOSE/TYPE UNSPECIFIED). SENSOR READINGS OF 4 MMOL/L AND 10 MMO/L WERE PLOTTED ON A PARKES ERROR GRID COMPARED TO 27.8 MMOL/L (HI) AND FELL INTO THE "D" AND "C" ZONES RESPECTIVELY, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252297 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