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

Lot Number KTP003311

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/14/2022

Event Type  Injury  

Event Description

After the sensor is placed and the 60 minute warmup period has passed the sensor sends an error saying "sensor not found" or "time to replace sensor." one sensor worked for about an hour then when the patient went to check the screen it said wait 10 minutes.After the 10 minutes had passed the patient tried to check the sensor again and it displayed an error saying "time to replace sensor." fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 2 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 14195155
• MDR Text Key: 290105442
• Report Number: MW5109327
• 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: 04/21/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Lot Number: KTP003311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• 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: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White