FDA Adverse Event Summary report: N

GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2)

MDR report key: 12554543 · Received September 29, 2021

Report

Report Number
MW5104301
Date Received
September 29, 2021
Date of Event
August 15, 2021
Report Date
September 28, 2021
Manufacturer
UNK
Product Code
MDS
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

PATIENT WAS STARTED ON FREESTYLE LIBRE 2 CGM (B)(6) 2021. PATIENT STATED HE WAS HAVING ISSUES WITH FINGERSTICK BG AND CGM GLUCOSE CORRELATION. HE DID STATE THIS CONTINUED DESPITE REPLACING HIS FREESTYLE LIBRE 2 GLUCOSE READER REPLACED. HIS SENSOR PACK CONSTRUCTION WAS APPROPRIATE. HIS SENSOR APPLICATION TECHNIQUE, WEAR TIME, AND SENSOR STORAGE WERE ALL APPROPRIATE. HE WAS NOT REUSING SENSORS. HE COULD NOT CONFIRM THE EXPIRATION DATE OF THE SENSORS HE WAS USING BUT HE STATED HE RECEIVED THEM RECENTLY FROM THE (B)(6). HE WAS NOT DEHYDRATED WHEN THE READINGS WERE NOT CORRELATING NOR WHERE THE READINGS TAKEN IMMEDIATELY AFTER EATING, GIVING INSULIN, OR EXERCISING. HE WAS NOT ON ASCORBIC ACID OR HIGH DOSE SALICYLIC ACID. THE SENSOR DID NOT GO THROUGH MRI/CT/X-RAY/HOT TUB/SAUNA. HE WAS NOT AN ANALYSIS PATIENT. HE DID NOT HAVE A PACEMAKER. HE DID NOT HAVE THE LOT NUMBER OF THE NON-WORKING SENSOR. HE DID ATTEMPT TO REPLACE THE SENSOR WITH A NEW SENSOR WITH SIMILAR RESULTS. HIS BLOOD GLUCOSE TEST STRIPS WERE NOT EXPIRED. HIS READINGS OF FINGERSTICK BG VS. LIBRE 2 CGM GLUCOSE ARE AS BELOW. DATE TIME FINGERSTICK BG FREESTYLE LIBRE 2 GM SYSTEM READING (B)(6) 2021 9 PM 108, 289 (B)(6) 2021 6 AM 103, 53. HIS READINGS AFTER BEING SWITCHED TO DEXCOM G6 GM VS. FINGERSTICK BG READING ARE AS BELOW. FINGERSTICK BG READING DEXCOM G6 CGM READING (B)(6) 2021 69, 67 111, 108 140, 143 (B)(6) 2021 106, 108, 76, 74, 129, 131, (B)(6) 2021 121, 121, 88, 91, 156, 157. SUSPECT DRUG# I DOSING: USE I SENSOR EVERY 14 DAYS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1442769 GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2) SENSOR, GLUCOSE, INVASIVE MDS UNK
1442770 GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2) SENSOR, GLUCOSE, INVASIVE MDS UNK

Patients

Seq Age Sex Outcome Treatment
1 63 YR