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

Model Number 71953-01

Device Problem Premature Discharge of Battery (1057)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 05/05/2023

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 date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in section h4 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 battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast-draining battery.As a result, customer experienced shakiness and tired and a border-line loss of consciousness, requiring third-party treatment of oral glucose.There was no report of death or permanent impairment 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 reader and kit pack for verification of correct cable and adapter was reviewed.The dhrs showed the libre reader passed all tests prior to release and correct cable and adapter was part of the kit pack.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 battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast-draining battery.As a result, customer experienced shakiness and tired and a border-line loss of consciousness, requiring third-party treatment of oral glucose.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated retained strips a visual inspection was performed on the returned reader and no issues were observed.Reader did not turn on with button press or with strip insertion.However, the reader did turn on with usb (universal serial bus) cable insertion.The reader log was downloaded and data/time were set successfully.The reader was sent for further investigation and de-cased.No physical damage was observed upon visual inspection.The returned reader was a observed to have a swollen battery.A known good battery was placed in the reader, and the reader was able to power on with button, strips, and usb cable.Therefore, issue is confirmed to swollen battery.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.As a result, customer experienced shakiness and tired and a border-line loss of consciousness, requiring third-party treatment of oral glucose.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: 16969201
• MDR Text Key: 315635943
• Report Number: 2954323-2023-20440
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2019
• 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