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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2021

Event Type  malfunction  

Event Description

Pt complaint that freestyle libre sensor kit only worked from (b)(6) 2021 to (b)(6) 2021.Reader said to change the sensor.Pt states the number from the sensor om000kd14y8, he also said that a similar problem last time.Pt wanted to formally express concern about this one.Mfr is doing a replacement, but since he is consistently having apparent mfg issues.He wants it documented.He does have the product available for return but mfr may be sending him a return mailer.

• Brand Name: FREESTLE LIBRE SENSOR KIT - 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 13093719
• MDR Text Key: 282955549
• Report Number: MW5106297
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2021
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male