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 Hyperglycemia (1905)

Event Date 07/17/2021

Event Type  No Answer Provided  

Event Description

Patient was prescribed freestyle libre 14 day glucose sensor.Patient's wife stated that patient was having greater than 20% discrepancy between libre 14 day readings and fingerstick blood glucose readings.Author discussed the following with the patient's wife and all of the follow item were being appropriately done or followed: sensor pack construction on a firm surface, appropriate application technique, appropriate sensor wear me, patient was not reusing sensors, sensors were stored correctly, sensors were not expired, patient was well hydrated and not critically ill, patient was not using high dose ascorbic acid or salicylic acid, patient did not have recent mri/ct/x-ray/diathermy/hot tub/sauna use, patient was not on dialysis and did not have a pacemaker.Lot number of non-working sensor was not available.Per patient's wife, sensor and reader had been replaced.Readings were as below: date time fingerstick bg reading freestyle libre cgm system reading (b)(6) 2021 8:00 pm 143 159, (b)(6) 2021 5:15 am 182 181, 5:52 pm 171 187, (b)(6) 2021 3:34 pm 250 212, (b)(6) 2021 6:45 pm 155 173, (b)(6) 2021 5:52am 198 162, 6:20 pm 174 135, (b)(6) 2021 8:10 am 153 112, 6:05 pm 219 171, (b)(6) 2021 4:40 am 166 131, patient was then changed to dexcom g6 cgm.Readings were as below.Date time fingerstick bg dexcom cgm reading (b)(6) 2021 5:11 am 139 143, (b)(6) 2021 4:11 pm 183 187, (b)(6) 2021 5:32 am 155 152, (b)(6) 2021 4:50 pm 170 162, (b)(6) 2021 5:40 am 125 117 (b)(6) 2021 5:38am 171 157.Symptoms: suspect drug # 1 dosing: use 1 sensor every 14 days for blood glucose monitoring.Dose or amount: 1 sensor, frequency: ud.Date of use: approximately (b)(6) 2020 through approximately (b)(6) 2021.Event abated after use stopped or dose reduced: yes.Diagnosis of use: diabetes mellitus.

• 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: 12496184
• MDR Text Key: 273559509
• Report Number: MW5104057
• Device Sequence Number: 1
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• 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: 73 YR
• Patient Weight: 57