MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2); SENSOR, GLUCOSE, INVASIVE

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)

Patient Problem Hyperglycemia (1905)

Event Date 02/09/2022

Event Type  Injury  

Event Description

Patient was started on freestyle libre 2 glucose sensor in 03/2021.Patient reported incongruent readings with sensor compared to fingerstick readings.Patient states he is placing the applicator and sensor pack together on a firm surface.Patient endorses appropriate application technique.Patient did state he was storing his sensors in the bathroom closet as opposed to a cool, dry place.He denies the sensor being expired.He denied severe dehydration, water loss, or being critically ill at the time of incongruent readings.He denied high dose ascorbic acid or salicylic acid use.He denied recent mri/ct/x-ray/hot tub/sauna use with sensor, being on dialysis, or having a pacemaker.He did not have the lot number of the non-working sensor.He states he had issues with multiple sensors.He did not replace the reader device.His blood glucose tests are not expired.Date time fingerstick bg reading freestyle libre cgm system reading 02/2022 am 192 242, 02/2022 overnight 132 64, 02/2022 152 213, (b)(6) 2022 am 172 131.Patient denies taking these above readings right after eating, dosing insulin, or exercising.Patient was switched to dexcom g6 (b)(6) 2022 and readings are as below.Date time prodigy dexcom (b)(6) 2022 10:00pm 215 170, (b)(6) 2022 6:00am 160 125 146 calib (b)(6) 2022 5:29 pm 192 169 181 calib, (b)(6) 2022 7:08 am 239 247, (b)(6) 2022 9: l 9 am 207 175, (b)(6) 2022 12:51 pm 179 189, (b)(6) 2022 10:32 am 137 115, 4/13/2022 8:58 am 120 140, (b)(6) 2022 9:44 am 169 160, (b)(6) 2022 12:30 pm 155 169.Suspect drug# 1, dosing: use 1 sensor every 14 days.Dates of use: (b)(6) 2021 - (b)(6) 2022.Diagnosis for use: diabetes mellitus.

• Brand Name: GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2)
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 14601632
• MDR Text Key: 293531695
• Report Number: MW5110101
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 73 KG