MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LITE BLOOD GLUCOSE MONITORING DEVICE; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number FREESTYLE LITE

Device Problem Defective Component (2292)

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

Event Date 07/09/2021

Event Type  Injury  

Event Description

Bought a brand new abbott freestyle lite blood glucose and monitoring system and went to use it and the lancelet did not work.I had just taken a tablet of metformin 500mg to start my diabetes treatment.The lancelet was defective and actually took it to the pharmacists and he could not make it work.They told me had to talk with manufacturer.Called abbott customer care so i could get an immediate replacement for the lancelet and they told me they would send one in one to two business days.As i have a tremendous headache i told them this was not acceptable.After giving my information numerous times i asked for supervisor.Told him i needed a replacement kit and he could not understand english well enough to help.Told him to call me back when he had a resolution after being on the call for over forty minutes.Finally called with some type of membership code and now i have to go back to the pharmacy and drive with a blinding headache to pick up a new freestyle kit.Lancelet is cheaply made with poor quality.Abbott has asked me to send the device to them.Please let me know if it should be sent elsewhere.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LITE BLOOD GLUCOSE MONITORING DEVICE
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 12160567
• MDR Text Key: 262027923
• Report Number: MW5102492
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00699073708052
• UDI-Public: 0100699073708052
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FREESTYLE LITE
• Device Catalogue Number: 70805
• Device Lot Number: 04B1740
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 118