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

Model Number 71992-01

Device Problems Unable to Obtain Readings (1516); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems Hypoglycemia (1912); Diaphoresis (2452); Confusion/ Disorientation (2553)

Event Date 02/17/2022

Event Type  Injury  

Manufacturer Narrative

The product data has been requested back for an investigation.The associated sensor is not expected to be returned as the device was reportedly discarded.A follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered in (date of event) is per report of "a year ago", from the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in (device manufacture date) is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a scan timeout error with the adc device, with use with phone application, and therefore did not have sensor readings or high/low glucose alarm.The customer became disoriented and sweaty, requiring treatment of glucose injection by relative.The customer was then transferred to hospital for additional treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

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 sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated and no physical damage was observed on the sensor patch.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Attempted communication between returned sensor and known good reader.Reader successfully communicated with the returned sensor.Scan timeout error message was not observed.An extended investigation has been performed for the returned sensor and did not observe any abnormalities.Attempts to replicate the users complaint using a using a known good android device and librelink app.The sensor was able to communicate without any issues.As the customer's complaint was not observed, this complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a scan timeout error with the adc device in use with (vivo v20/so:(b)(6)) phone application, and therefore did not have sensor readings or high/low glucose alarm.The customer became disoriented and sweaty, requiring treatment of glucose injection by relative.The customer was then transferred to hospital for additional treatment.There was no report of death or permanent injury 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: 16476262
• MDR Text Key: 310585683
• Report Number: 2954323-2023-08715
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K210943
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: 71992-01
• Device Catalogue Number: 71857-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2022
• 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