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); Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Blurred Vision (2137); Polydipsia (2604)

Event Date 08/15/2022

Event Type  Injury  

Manufacturer Narrative

The customer¿s product has been requested for investigation.A follow-up report will be filed 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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported receiving a sensor error message upon scanning the adc device.The customer felt hyperglycemic with symptoms of blurred vision, thirst, and couldn't stand.The customer was unable to self-treat and was treated with 4 ui novorapid insulin administered by mother.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has 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 sensor and libre sensor kits 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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported receiving a sensor error message upon scanning the adc device.The customer felt hyperglycemic with symptoms of blurred vision, thirst, and couldn't stand.The customer was unable to self-treat and was treated with 4 ui novorapid insulin administered by mother.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported receiving a sensor error message upon scanning the adc device.The customer felt hyperglycemic with symptoms of blurred vision, thirst, and couldn't stand.The customer was unable to self-treat and was treated with 4 ui novorapid insulin administered by mother.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated and corrosion was observed through the sensor plug casing.Data was extracted using approved software and sensor was found to be in sensor state 6 (indicating abnormal termination).Visual inspection performed on the sensor plug assembly and no failure modes observed.An extended investigation has also been performed.Performed a visual inspection on the returned sensor, observed corrosion through the base of returned sensor.The sensor was de-cased.Visual inspection was performed on the pcba (printed circuit board assembly) and observed corrosion by battery on pcba due to liquid ingress.The returned battery was measured to be out of specification.Therefore, this issue is confirmed to liquid ingress.All pertinent information available to abbott diabetes care has been submitted.

• 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: 15278443
• MDR Text Key: 298431648
• Report Number: 2954323-2022-30562
• 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,Followup
• Report Date: 02/20/2023

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: 07/31/2023
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 01/21/2023
• Supplement Dates FDA Received: 09/06/2022; 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• 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