MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 71953-01

Device Problems No Display/Image (1183); Unable to Obtain Readings (1516)

Patient Problem Hyperglycemia (1905)

Event Date 02/24/2023

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.N/a was selected for pma/510(k) as customer is using fs libre 3 sensor with fs libre reader.Fs libre 3 sensor with reader is not approved for market in us, however libre 3 is same/similar to libre 2 which is currently on market in the us.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A display issue was reported with the adc device.A customer reported that the adc device depicted a white screen and was therefore unable to obtain monitor glucose.The customer experienced a symptom described as "high sugar" and was able to self-treat.The customer had contact with a healthcare professional and was administered insulin (dose/type unknown) for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection was performed on the returned reader and observed reader to be damaged due to use related issue.Therefore, this issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A display issue was reported with the adc device.A customer reported that the adc device depicted a white screen and was therefore unable to obtain monitor glucose.The customer experienced a symptom described as "high sugar" and was able to self-treat.The customer had contact with a healthcare professional and was administered insulin (dose/type unknown) for treatment.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16632727
• MDR Text Key: 312191598
• Report Number: 2954323-2023-12483
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other