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

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 03/01/2020

Event Type  malfunction  

Event Description

Pt getting sensor expired error message happened on 4 out of 6 boxes.Began in (b)(6) 2020 on prev sensors, pt reached out one time to mfr and one replacement sent to pt and was told they would not replace again.

• Brand Name: FREESTYLE LIBRE SENSOR KIT 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 10471658
• MDR Text Key: 205095638
• Report Number: MW5096330
• Device Sequence Number: 3
• 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: 08/13/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 61 YR