MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY CGM; SENSOR, GLUCOSE, INVASIVE

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Rash (2033)

Event Type  malfunction  

Event Description

I have type 1 diabetes and began using the freestyle libre 10 day continuous glucose meter.Did not have any problems with the 10 day cgm and the readings were accurate.Then in (b)(6) 2018 abbott labs stopped making the 10 day cgm and replaced it with the 14 day cgm stating it was better.I was not.Out of the 16 sensors i used only 1 stayed on 14 days and was fairly accurate.The blood sugar readings on the other 15 cgm sensors were 60 to 100 points different than the readings i took with a blood glucose meter.The reading difference is significant, i am dependent on an accurate blood glucose reading to administer the correct dosage of insulin pump for my life and to make adjustments if my blood sugar is falling too quickly.The libre 14 day cgm failed to provide accurate readings putting my life at risk.The 15 out of 16 sensors i used were suppose to last for 14 days.They did not.They lasted a range of 6 to 10 days.Also, abbott labs changed the type of adhesive used in the 10 day to 14 day sensors.The 10 day sensor stayed attached and i did not have any reaction to the adhesive.With the switch to the 14 day sensor the company reps did state the adhesive had been changed.The new adhesive caused a severe rash on me.I contacted the abbott labs libre cgm customer division several times to inform the company of the issues i was having.The company does not seem concerned about its customers.The hold time to get through to a company rep was anywhere 25 to 45 mins.When i told them of the issues i was having they were not too concerned and stated a difference between the readings of my blood glucose meter and their cgm were normal.A 60 to 100 point difference is not normal and that much of a point difference is not reflected in the companies literature.This product is dangerous for anyone with type 1 diabetes due to the inaccurate readings and the product does not last for 14 days, so the consumer is out a great deal of money for a defective product.Incorrect blood sugar reading.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8772590
• MDR Text Key: 150821464
• Report Number: MW5087954
• 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: Patient
• Type of Report: Initial
• Report Date: 07/04/2019
• 15 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 72