MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71953-01

Device Problem Power Problem (3010)

Patient Problem Hypoglycemia (1912)

Event Date 03/21/2023

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 exact date that the incident occurred is unknown.The date entered is based on the customer report of "a week ago" from adc awareness date.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a delivery issue with a replacement adc device.The customer initially reported a battery/no power issue was reported with the adc device not charging or turning on due to a damaged port.A replacement device was ordered however, the customer did not receive the replacement device and the customer was unable to monitor their glucose.The customer was unable to self-treat due to unspecified symptoms and required third-party treatment of glucagon.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 has been performed on the returned reader and damaged usb port was observed.The damaged usb port prevented the customer from charging the reader which led to the reader not turning on.The reader was de-cased and placed into the reader test fixture to download log.The issue is not confirmed to use.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a delivery issue with a replacement adc device.The customer initially reported a battery/no power issue was reported with the adc device not charging or turning on due to a damaged port.A replacement device was ordered however, the customer did not receive the replacement device and the customer was unable to monitor their glucose.The customer was unable to self-treat due to unspecified symptoms and required third-party treatment of glucagon.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16701487
• MDR Text Key: 312882303
• Report Number: 2954323-2023-13920
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K193371
• 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: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• 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: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention