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

Model Number FREESTYLE LIBRE 14 DAY

Device Problems Loss of or Failure to Bond (1068); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Erythema (1840); Irritation (1941); Swelling (2091)

Event Date 11/21/2019

Event Type  malfunction  

Event Description

The abbott freestyle libre reader was reading normal blood sugar level, but my glucose was actually 56.The sensors have been repeatedly failing after 6-8 days but they are approved for 14.The adhesive is irritating causing redness and swelling.The sensor adhesive begins failing after 5 days.I have my reading device that has some of the sensor failure dates, but i'm not sure how many.I did contact abbott and they authorized replacements but that doesn't work with prescriptions.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 9445889
• MDR Text Key: 170281964
• Report Number: MW5091554
• 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: Patient
• Type of Report: Initial
• Report Date: 12/05/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FREESTYLE LIBRE 14 DAY
• Device Catalogue Number: 0M006167YG0
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 94