MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY SENSOR FLASH GLUCOSE MONITORING SYSTEM; SENSOR, GLUCOSE, INVASIVE

Lot Number 190315Q

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2019

Event Type  malfunction  

Event Description

"sensor not found" error with freestyle libre 14 day sensor.Multiple occurrences over the last 45 days, where some sensors would function properly, but others would not.Pt reported initial occurrences to mfr, and mfr provided replacement.Pt had same issue with another box of sensors, and reported it to me.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY SENSOR FLASH GLUCOSE MONITORING SYSTEM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC. ; alameda CA 94502
• MDR Report Key: 8785147
• MDR Text Key: 150999309
• Report Number: MW5088039
• 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: 07/09/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Lot Number: 190315Q
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR