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); Hot Flashes/Flushes (2153); Diaphoresis (2452)

Event Date 06/11/2022

Event Type  Injury  

Event Description

A customer reported a fast-draining battery issue with the adc device and a result was unable to use to scan their sensor.The customer experience symptoms of heat, sweats, and required treatment of sugar water from spouse.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

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

Event Description

A customer reported a fast-draining battery issue with the adc device and a result was unable to use to scan their sensor.The customer experience symptoms of heat, sweats, and required treatment of sugar water from spouse.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 reader were reviewed and the dhrs showed the 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.

Event Description

A customer reported a fast-draining battery issue with the adc device and a result was unable to use to scan their sensor.The customer experience symptoms of heat, sweats, and required treatment of sugar water from spouse.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.Reader was sufficiently charged.De-cased the reader and performed power consumption test and all results were within specification.Therefore, issue is not confirmed.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: 14958553
• MDR Text Key: 295510105
• Report Number: 2954323-2022-23113
• 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: 12/21/2022

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 Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/11/2022; 12/09/2022
• Supplement Dates FDA Received: 07/19/2022; 12/22/2022
• 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