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

Model Number 72114-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Chills (2191); Dizziness (2194); Diaphoresis (2452)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.This report is being filed on an international product, model number 72114-01, which has a similar product distributed in the u.S., model number 71992-01.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a signal loss issue with the adc device.The customer was therefore unaware of changes in glucose levels and experienced dizziness and cold sweats.The customer went to hospital where a diagnosis of hypoglycemia was made, and customer was treated with a glucose injection.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) was returned and investigated.Visual inspection was performed on the returned sensor, no issues were observed.Data was extracted using approved software, and extraction was successful.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a signal loss issue with the adc device.The customer was therefore unaware of changes in glucose levels and experienced dizziness and cold sweats.The customer went to hospital where a diagnosis of hypoglycemia was made, and customer was treated with a glucose injection.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported a signal loss issue with the adc device.The customer was therefore unaware of changes in glucose levels and experienced dizziness and cold sweats.The customer went to hospital where a diagnosis of hypoglycemia was made, and customer was treated with a glucose injection.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Extended investigation was performed.Visual inspection was performed on the returned patch and any evidence of misuse or abnormalities was not observed.The returned patch data was extracted.Glucose solution test was performed on the returned patch and monitored it's bluetooth connection for any missing data throughout the test.Any dropped packets or abnormal glucose readings during testing was not observed , indicating that the returned patch did not have any defects causing signal/connection issues.No malfunction or product deficiency was identified.Therefore this issues is not confirmed.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: 14274671
• MDR Text Key: 290642960
• Report Number: 2954323-2022-14213
• 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,Followup
• Report Date: 08/09/2022

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: 05/31/2022
• Device Model Number: 72114-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 07/12/2022; 07/28/2022
• Supplement Dates FDA Received: 07/26/2022; 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2021
• 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