MAUDE Adverse Event Report: ABBOTT DIABETIC CARE, INC. FREESTYLE LIBRE 3 SENSOR; SENSOR, GLUCOSE, INVASIVE

Model Number 3 57599 81800 5

Device Problems Product Quality Problem (1506); Failure to Transmit Record (1521); Failure to Sense (1559); Defective Component (2292); Detachment of Device or Device Component (2907); Activation Failure (3270)

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

Event Date 06/17/2023

Event Type  malfunction  

Event Description

I was prescribed freestyle libre 3 in (b)(6) 2022 and have used it almost continuously since then.The device is designed to have a two week lifespan, after which it must be replaced.Notwithstanding that i have carefully followed all the prerequisites for application and use, i have experienced: multiple failures to send data, sensors falling off the arm, sensors not working, sensors that do not stick when applied and, a sensor that failed to deploy at all.Abbott has replaced 10 sensors in this nearly 6 month period, in which, at most, i would have used 13, a failure rate of 77% due to, in my opinion, shoddy manufacturing.On saturday, (b)(6) 2023, abbott compounded their sorry performance by informing us they would not replace any more sensors.They are at fault and we have to pay for the abysmal quality of their devices,, if we wish to continue to use the device our endocrinologist has prescribed.They informed us they would not permit us to reach anyone in higher authority in order to attempt to rectify the situation.During the 6 months, i several times offered to send them back the defective part, but they mostly refused.I think a manufacturer of a medical device should be made to stand behind the product they are allowed to sell and should be bound by the local laws concerning warranties of fitness for a particular purpose and merchantability and not be permitted to arbitrarily decide that "10 is too much" when 10 have failed through no fault of the patient and entirely the fault of the manufacturer.If there are any other or further details you would like or require, please do not hesitate to reach out to my spouse, who will be glad to cooperate to the fullest extent possible.Reference report: mw5118765; mw5118766; mw5118767; mw5118768; mw5118769; mw5118770; mw5118771; mw5118772; mw5118773.

• Brand Name: FREESTYLE LIBRE 3 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETIC CARE, INC.
• MDR Report Key: 17198595
• MDR Text Key: 317919640
• Report Number: MW5118764
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2023
• Device Model Number: 3 57599 81800 5
• Device Lot Number: T60000991
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; BUPROPRION; CRESTOR; ELIQUIS; JARDIANCE; KEPPRA; METOPROLOL TARTRATE; MODAFINIL; MONTELUKAST; PEPCID; PIOGLITIZONE; PRESERVISION; SYNTHROID; TUEJEO INSULINE GLARGINE; VITAMIN D 50,000 IU ONCE EVERY 2 WEEKS, BY RX, ; ZETIA
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White