MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Model Number JCGA 297-T2065-

Device Problems Use of Device Problem (1670); Component Missing (2306); Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2021

Event Type  Injury  

Event Description

At the beginning of (b)(6) 2021, the freestyle libre equipment was acquired in the city of (b)(6).Later, this equipment is sent via (b)(6) by (b)(6) to (b)(6).And after 2 months, the team.On (b)(6) 2021, we contacted the abbott (b)(6) call center.Through the operator, we explained that we had placed a first sensor, and the device threw us an error.Then a second and a third sensor, and in all cases we get the same error.All these error codes were reported to the operator, who was able to verify that these errors recorded that the device was bad, from the place where the team was assembled.At this moment, the operator informs us that abbott will send a new freestyle libre equipment, to an address in (b)(6), in a period of time between 7 to 10 business days.On july 16, 2021, the second freestyle team to (b)(6).And then this device is sent to (b)(6), arriving at the destination country, on 01-sep-2021.Then the first sensor was placed, and the device threw us an error.Subsequently i put a second and a third sensor, and the team kept throwing an error, as it happened with the first freestyle libre device sent.Then we proceeded to review the errors of the equipment, and i report the same error codes of the previous team freestyle libre.This second device, once reviewed, we noticed that it arrived with a label on the box, which said sample equipment, and also, this device came without a charger.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 12697093
• MDR Text Key: 278810770
• Report Number: MW5104934
• Device Sequence Number: 2
• Product Code: QLG
• Combination Product (y/n): Y
• Reporter Country Code: VE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/21/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: JCGA 297-T2065-
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 62