MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY); SENSOR, GLUCOSE, INVASIVE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2021

Event Type  No Answer Provided  

Event Description

Patient stated he had been having falsely low blood glucose readings with the freestyle libre 14 day compared to his blood glucose finger stick readings.Author reviewed application technique, storage instructions, sensor expiration dates, and medication interactions with the patient.Patient was using one sensor in the belly and on sensor in the arm beyond that, patient seem to be using the freestyle libre 14 correctly.Patient collected information about fingerstick bg readings vs.The freestyle libre 14 day readings over the past week.Some of the readings are as below.These readings have a greater than 20% variance and are not done right after eating, dosing insulin, or exercising.The readings were off regardless of using the sensor in the belly or the arm date time fingerstick bg freestyle libre 14 cgm system (b)(6) 2021 1115 am (before lunch) 142/59; on (b)(6) 2021 6 am (before breakfast) 140/73; on (b)(6) 2021 10 am (2 hours after eating) 202/103; on (b)(6) 2021 305 pm (before dinner) 158/81; on (b)(6) 2021 720 am (before breakfast) 121/54; on (b)(6) 2021 645 am (before breakfast) 137/42; on (b)(6) 2021 115 pm (2 hours after lunch) 117/87; on (b)(6) 2021 540 am (before breakfast) 136/95.Pt was approved for the dexcom g6 cgm.Readings were as follows: date time fingerstick bg reading dexcom cgm system reading (b)(6) 2021 230 pm 136/156; on (b)(6) 2021 330 pm 133/144; on (b)(6) 2021 5 pm 118/113; on (b)(6) 2021 730 am 100/100; on (b)(6) 2021 1055 am 118/123; on (b)(6) 2021 115 pm 94/91; on (b)(6) 2021 425 pm 124/125; on (b)(6) 2021 635 am 129/110; on (b)(6) 2021 11 am 173/166.5; on (b)(6) 2021 135 pm 150/141; on (b)(6) 2021 425 pm 106/109; on (b)(6) 2021 1018 am 134/122.Syspect drug# 1 dosing: use 1 sensor everyn 14 days for blood glucose monitoring.

• Brand Name: GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 12040318
• MDR Text Key: 258891325
• Report Number: MW5101995
• Device Sequence Number: 2
• Product Code: MDS
• Combination Product (y/n): Y
• 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: 06/16/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 49