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

Model Number 71992-01

Device Problem Packaging Problem (3007)

Patient Problems Hypoglycemia (1912); Convulsion/Seizure (4406)

Event Date 09/13/2022

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 device manufacturing date is unknown.The date entered in is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported a packaging issue stating adc device was missing and was unable to obtain readings.Customer further reported experiencing "sugar was lower than 50 mg/dl on glucometer and was convulsing," a seizure and was unable to self-treat.The customer received third-party intervention who provided a glucagon iv, unspecified dose of levamir insulin, "defibrillator" as treatment for the diagnosis of hypoglycemia.No additional information was provided.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 sensor was reviewed and the dhrs showed the libre sensor 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

Customer reported a packaging issue stating adc device was missing and was unable to obtain readings.Customer further reported experiencing "sugar was lower than 50 mg/dl on glucometer and was convulsing," a seizure and was unable to self-treat.The customer received third-party intervention who provided a glucagon iv, unspecified dose of levamir insulin, "defibrillator" as treatment for the diagnosis of hypoglycemia.No additional information was provided.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: 15602032
• MDR Text Key: 301720234
• Report Number: 2954323-2022-37854
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: 00357599800000
• 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
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Model Number: 71992-01
• Device Catalogue Number: 71992
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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
• Patient Sex: Male