FDA Adverse Event Summary report: N

GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2)

MDR report key: 11854970 · Received May 19, 2021

Report

Report Number
MW5101445
Date Received
May 19, 2021
Date of Event
March 22, 2021
Report Date
April 23, 2021
Manufacturer
ABBOTT DIABETES CARE INC.
Product Code
MDS
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

PATIENT WAS USING FREESTYLE LIBRE 2 CONTINUOUS GLUCOSE MONITORING SYSTEM. PATIENT REPORTED HIS CGM READINGS WERE SUBSTANTIALLY LOWER THAN HIS FINGERSTICK BG READINGS. PATIENT STATED ALL THE BG READINGS WERE TAKEN PRIOR TO MEALS. AUTHOR VERIFIED SENSOR APPLICATION TECHNIQUE AND STORAGE INSTRUCTIONS WITH THE PATIENT. PATIENT DENIED ANY USE OF CONCOMITANT MEDICATIONS THAT MAY EFFECT THE CGM READINGS. READINGS PATIENT GAVE ARE AS BELOW: (B)(6) 2021 1230 PM: FINGERSTICK 142, FREESTYLE 74, (B)(6) 2021 530 PM: FINGERSTICK 180, FREESTYLE 136, (B)(6) 2021 BREAKFAST READING 9: FINGERSTICK 147 AND FREESTYLE WAS 60; (B)(6) 2021 NOON READING: FINGERSTICK 220 AND FREESTYLE 76, (B)(6) 2021 530 PM SUPPER: FINGERSTICK 125 AND FREESTYLE WAS 53, (B)(6) 2021 630PM: FINGERSTICK 222, FREESTYLE 147 PATIENT WAS SWITCHED TO DEXCOMG6 CGM. DEXCOMCGM READINGS ARE AS FOLLOWS: (B)(6) 2021 615 PM, FINGERSTICK: 156, DEXCOM 152, (B)(6) 2021 9 PM: FINGERSTICK 243, DEXCOM240; (B)(6) 2021 BREAKFAST: FINGERSTICK 166, DEXCOM 145,(B)(6) 2021 LUNCHTIME: FINGERSTICK 128, DEXCOM 115, (B)(6) 2021 DINNER: FINGERSTICK208, DEXCOM 180, (B)(6) 2021 NIGHTTIME: FINGERSTICK220, DEXCOM 171, (B)(6) 2021 BREAKFAST: FINGERSTICK 180, DEXCOM 158, (B)(6) 2021 LUNCHTIME: FINGERSTICK 189, DEXCOM 156, (B)(6) 2021 DINNER: FINGERSTICK 165, DEXCOM 141, (B)(6) 2021 NIGHTTIME: FINGERSTICK 250, DEXCOM 158 (BEFORE INSULIN AND NOT AROUND EATING); (B)(6) 2021: BREAKFAST: FINGERSTICK 125, DEXCOM 120, (B)(6) 2021: LUNCHTIME: FINGERSTICK 175, DEXCOM 151, (B)(6) 2021: DINNER: FINGERSTICK213, DEXCOM 179, (B)(6) 2021: NIGHTTIME: FINGERSTICK257, DEXCOM 163 MORE OF THE DEXCOM READINGS APPEARED TO BE WITHIN THE 20% RANGE. SYMPTOM: SUSPECT DRUG# 1, DOSING: USE 1 SENSOR AS DIRECTED EVERY 14 DAYS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
742866 GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2) SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE INC.

Patients

Seq Age Sex Outcome Treatment
1 81 YR