MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 SENSOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Lot Number KTP00 7000

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)

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

Event Date 09/28/2023

Event Type  Injury  

Event Description

Da picked up a refill of 6 freestyle libre senors, a 84-day supply on (b)(6) 2023.Da has been filling rxs for freestyle libre 2 sensors regularly since (b)(6) 2022 without missing a refill date, so they have plenty of experience using the product.Today, (b)(6) 2023 she reported to the pharmacy, safeway pharmacy #1847, that she tried using 3 sensors, from two different lots, which were defective.She said an unusual pin was sticking out of the back of the sensor and grabbing onto her sweater.She believes that pin is used to insert the sensor fiber into the skin that reads the blood glucose levels, however neither of the three sensors she tried were reading her blood glucose.At first, she thought it was a technical error between the reader and the sensor software when she wasn't getting reading, until she realized sensor was grabbing onto her sweater and further inspection showed that a small part of a needle/pin was exposed.She received 6 sensors and said she had the same issue with 2 sensors from lot ktp007000 and 1 sensor from lot ktp007114.Reference reforts: mw5146496, mw5146498.

• Brand Name: FREESTYLE LIBRE 2 SENSOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 17868816
• MDR Text Key: 325267270
• Report Number: MW5146497
• Device Sequence Number: 1
• Product Code: QLG
• 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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: KTP00 7000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Ethnicity: Non Hispanic
• Patient Race: White