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

Model Number 71953-01

Device Problem Failure to Charge (1085)

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

Event Date 09/30/2021

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 exact date of event is unknown.The date is per the customer's report of "last september." all pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a battery/power issue with the freestyle libre 2 reader.The customer indicated upon plugging in the reader they observed "battery low connected to computer", and noted that the reader battery was "dead".The customer experienced a loss of consciousness and customer was treated with wife and ambulance personnel with orange juice.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 specifications.Dhrs for the fs libre reader was reviewed and the dhrs showed the fs libre reader passed all tests prior to release.If the product is returned, the case will be re-opened, and a physical investigation will be performed all pertinent information available to abbott diabetes care has been submitted.The exact date of the event is unknown.The date entered in section b3 is per the customer's report of "last september.".

Event Description

A customer reported a battery/power issue with the freestyle libre 2 reader.The customer indicated upon plugging in the reader they observed "battery low connected to computer", and noted that the reader battery was "dead".The customer experienced a loss of consciousness and the customer was treated with wife and ambulance personnel with orange juice.There was no report of death or permanent impairment associated with this event.

Event Description

A customer reported a battery/power issue with the freestyle libre 2 reader.The customer indicated upon plugging in the reader they observed "battery low connected to computer", and noted that the reader battery was "dead".The customer experienced a loss of consciousness and the customer was treated with wife and ambulance personnel with orange juice.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the reader and damaged usb port was observed.Due to the damaged usb port the reader was not able to be charged and so the reader did not power on.The reader was further de-cased and placed into the reader test fixture to download log.Therefore, issue is not confirmed to use.Although glucose results may be delayed, blood glucose could be determined by alternate means, including use of another blood glucose meter, seeing a physician (as recommended in product labeling), or by seeking treatment at a health care facility.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: 13569452
• MDR Text Key: 285943591
• Report Number: 2954323-2022-05909
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: 00357599803001
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Device Catalogue Number: 71953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2020
• 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
• Patient Sex: Male
• Patient Weight: 64 KG