MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE CGM; FREESTYLE LIBRE PRO FLASH

Device Problem Device Sensing Problem (2917)

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

Event Date 05/05/2018

Event Type  malfunction  

Event Description

My husband and i found that the freestyle libre has false advertised their product.The product is unreliable for no stick glucose.We found that there was great discrepancy from the cgm and the finger stick.We could not rely on the freestyle libre totally for our blood glucose.

• Brand Name: FREESTYLE LIBRE CGM
• Type of Device: FREESTYLE LIBRE PRO FLASH
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 7742317
• MDR Text Key: 116068559
• Report Number: MW5078768
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 74