MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 CGM SENSOR; SENSOR, GLUCOSE, INVASIVE

Model Number LIBRE 2

Device Problems Unable to Obtain Readings (1516); Defective Device (2588); Application Program Problem (2880); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

Event Type  malfunction  

Event Description

Abbott freestyle libre 2 continuous glucose monitoring sensors have repeatedly failed today.The first occurred when i tried to replace a sensor early, and due to an unannounced change to the programming of the libre2 reader device, i was unable to override the old sensor that was about to expire and initialize a new one.I removed that sensor and it was rendered unusable.The next two sensors i tried to activate both failed to ever initialize and provide a reading.The reader device itself is currently unable to recognize blood glucose test strips, and this currently leaves me with no way to check my blood glucose levels as a type 1 diabetic.I have lost count of the total number of sensors that have failed before their 14-day window, or failed to initialize altogether, during my two years of using this product.I believe the unreliability of the product is a serious risk to the health and well-being of insulin-dependent diabetics who rely on them to monitor their blood glucose levels.Reference reports: mw5118454, mw5118456.

• Brand Name: FREESTYLE LIBRE 2 CGM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17162996
• MDR Text Key: 317561148
• Report Number: MW5118455
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: LIBRE 2
• Device Lot Number: KTP006067
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: FREESTYLE LIBRE 2 CGM, INSULIN LISPRO, LEVEMIR BASAL INSULIN.
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White