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

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 07/01/2019

Event Type  malfunction  

Event Description

Freestyle 14 day cgm keep falling off before 14 days.I've used in the past month, one for 14 days, one fell off after 10 days, and today after 3 days of use the last one fell off.I'm very experienced using 10 days cgm for over a year and only had one fall off.I was made to switch to the 14 day because i was told they no longer make the 10 day.I complained to abbott lab via their (b)(6) page and after reading other complaints about this, this seems to be an increasing ongoing problem with quality of the medical device.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE 14 DAY CGM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8760008
• MDR Text Key: 150172084
• Report Number: MW5087845
• Device Sequence Number: 2
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/01/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 122