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

Model Number FREESTYLE LIBRE SCANNER AND SENS

Device Problems Labelling, Instructions for Use or Training Problem (1318); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2020

Event Type  malfunction  

Event Description

Use of freestyle libre (elderly patients).Mom just started to use the freestyle libre cgm.The first two sensors failed after 15h.She is on sensor 4.So far, she has not installed the sensor by herself.She mistook the screen after activation as her glucose is 60 rather than "your sensor can be used in 60 minutes".That screen needs a unit.E.G.60s and not just 60 or a countdown timer in say 59:30 and start counting down.No treatment decisions were made because i was there.Mom has never had a computer or cell phone of her own.All in all, the instructions were really good.I'll repeat some of my comments here which i have brought to the company's attention.The one above was not.Their quick start guide does not mention "hold scanner within 1.5 inches of sensor".I was thinking bluetooth and not nfc communications.The photos in the manual should show scanning of the sensor with the back of the meter facing the sensor and not the lcd.When you scan with the lcd facing the sensor there is a possibility of accidentally selecting another menu after the scan is complete.This avoids "i didn't get a reading".It's not a requirement.It's just better.Setting vibrate works very well.Binary set-up responses should use a slide gesture to avoid accidental change.The fact that installation tool "inserts a fiber" with a needle and not a metallic needle which remains in the arm should be known early in the quick start guide.The enclosure is too slippery.I added a piece of food grade silicone with a psa (pressure sensitive adhesive) was added to one side.Disposal of the sensor.They don't address it.You basically have a bio-hazard combined with a silver oxide (hearing aid) battery.The sensor is not marked accordingly.There is "no household waste icon (trash can with an x".I will likely dispose of it in the following way: wipe the patient side down with either 3% or 17% hydrogen peroxide; remove the sensing element.It can easily be pried out with a screwdriver.Dispose in sharps container; dispose of electronics and battery in e-waste or household battery stream.Bio-waste is usually disposed of using incineration and incinerating batteries could release toxic compounds.There could be a tiny amount of blood or tissue liquid remaining on the thread or the sensor body.Once the unit is on, an accelerometer such as the bma400 ic could be used to keep the display active.This behavior should be a configurable option.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 10217539
• MDR Text Key: 197310486
• Report Number: MW5095294
• Device Sequence Number: 2
• Product Code: PZE
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/26/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FREESTYLE LIBRE SCANNER AND SENS
• Device Catalogue Number: 71938-01
• Device Lot Number: 05A090D
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 93 YR
• Patient Weight: 64