MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Description

A "xxxxxxxxx xxxxxxxx" ambulatory care coordinator identified after discussion with the patient/caregiver the need for an additional sensor for her freestyle libre continuous blood glucose monitor.The ambulatory care coordinator contacted the health system ambulatory pharmacist regarding the patient need.The health system pharmacist discussed the case with the patient.The patient stated she was in dire need for a replacement sensor for her freestyle libre.The health system pharmacist directed her to call the abbott customer care team ((b)(4)) to request a replacement sensor at no cost.The health system pharmacist called her back after one hour to follow up, and she was told by the customer care team that they cannot send her a replacement sensor due to her "state sponsored insurance plan".The health system pharmacist volunteered to find her a replacement sensor, but first needed to know if the patient had the freestyle libre 14 day or libre 2, so they asked her to take a picture of her device and send it via mychart.It appeared to health system pharmacist that the patient had the freestyle libre 14 day system from the pictures of the reader.The patient told the health system pharmacist that a nurse for the prescribing endocrinologist looked at the pictures and told her that it was the libre 2.This confused the health system pharmacist because the pictures look like libre 14 day reader.Also confusing was that the prescription was electronically submitted to the dispensing pharmacy for the freestyle libre 2.So the health system pharmacist called the dispensing pharmacy and spoke to the pharmacist.The dispensing pharmacy pharmacist investigated the patient's freestyle libre prescription and it was confirmed that the prescription was electronically submitted for freestyle libre 2.However the pharmacy incorrectly dispensed a freestyle libre 14 day.The pharmacy acknowledged their error and agreed to provide the correct sensor.The following day, the health system pharmacist called the patient to follow up.She mentioned that she did go to the pharmacy and her device was replaced with the correct freestyle libre 2.She mentioned that they only gave her one sensor with her reader instead of the standard 30-day supply of two sensors.They told her that she is only allotted one sensor.The health system pharmacist called the dispensing pharmacy and spoke to the dispensing pharmacist again.The pharmacy was resistant on dispensing another sensor due to financial loss to the pharmacy.After intense discussions, the pharmacy finally agreed to expedite ship an additional sensor to the patient's home at no additional cost, and the pharmacy will pay any expenses incurred.Communication, poor / lacking (nonspecific) similar names; verbal and written.(b)(6).

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 12908472
• MDR Text Key: 281939768
• Report Number: MW5105676
• Device Sequence Number: 2
• Product Code: PZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/02/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1