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

Device Problem Communication or Transmission Problem (2896)

Patient Problem Hypoglycemia (1912)

Event Date 09/25/2021

Event Type  Injury  

Event Description

Consistent issues with freestyle libre losing communication with reader.My son has had this issue dozens of times a month for a year.It is not related to a specific reader (we've had 3) or sensor.It loses connection even when less than 10 feet away with no obstructions.He can tank from 130 to 40 or lower bg in less than an hour.Abbott refuses to let me speak to someone that can shed light on how common this is.They can only offer a new reader or sensor - which has not helped.Many of my other patients in my pharmacy have the same issues.For dm2, not such a huge issue - but it is frustrating to them.Can be deadly for type 1 dm.I understand that cgm devices can have varying results compared to finger stick.However, it is not acceptable for the device to lose connection so very often.In the very least, the reader should alarm if it loses contact with the sensor for more than 15-30 minutes.This should be required by the fda.In the meantime, we try to get up and check him every 2 hours, but even so - we have had to use glucagon far too often.This device is dangerous and needs to be checked for connection issues and required to alarm when connection is lost.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 12547323
• MDR Text Key: 274065599
• Report Number: MW5104268
• Device Sequence Number: 1
• Product Code: MDS
• 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: 09/26/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 10 YR
• Patient Weight: 29