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

Model Number 72081-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Discomfort (2330); Numbness (2415)

Event Date 03/30/2023

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 record) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.As the operating system is unknown, g4 - pma/510(k) # is populated for ios.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A webform complaint was received in which it was reported a customer received a "scan again in 10 minutes" message on the adc device and was unable to obtain readings.The customer was contacted and reported that as a result, customer experienced symptoms described as feeling "bad, feet felt paralyzed, and no feeling in hands" and required third-party intervention of fruit juice and glucose from spouse.No further details were provided.There was no report of death or permanent impairment associated with this event.

Event Description

A webform complaint was received in which it was reported a customer received a "scan again in 10 minutes" message on the adc device and was unable to obtain readings.The customer was contacted and reported that as a result, customer experienced symptoms described as feeling "bad, feet felt paralyzed, and no feeling in hands" and required third-party intervention of fruit juice and glucose from spouse.No further details were provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) was returned and investigated.Visual inspection was performed and no issues were observed on sensor patch.Data was successfully extracted from the returned sensor using approved software.The sensor data was reviewed and signal low error message along with a drop in glucose/temp values were observed, indicating that the user removed the sensor early.This issue is not confirmed to early sensor removal.All pertinent information available to abbott diabetes care has been submitted.

• 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: 16725350
• MDR Text Key: 313149978
• Report Number: 2954323-2023-14428
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K213132
• 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: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 04/22/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention