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

Model Number 71953-01

Device Problems Premature Discharge of Battery (1057); Unable to Obtain Readings (1516)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 11/13/2023

Event Type  Injury  

Event Description

A battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery and the screen appearing black.As a result, customer experienced loss of balance and loss of consciousness and was unable to self-treat, requiring treatment of glucosprint and "5 sugar sachets" provided by non-hcp.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.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 review) for the freestyle libre reader were reviewed and the dhrs showed the freestyle libre reader 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.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.Reader was sufficiently charged.The reader was de-cased for further inspection and no contamination, corrosion, or damage was observed on the printed circuit board.The stm processor was present.Power consumption test performed and was within specifications.No malfunction or product deficiency has been identified.Therefore, issue is not confirmed due to fast draining battery not observed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery and the screen appearing black.As a result, customer experienced loss of balance and loss of consciousness and was unable to self-treat, requiring treatment of glucosprint and "5 sugar sachets" provided by non-hcp.No further treatment was reported.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: 18228755
• MDR Text Key: 329260379
• Report Number: 2954323-2023-51832
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2022
• 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