MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problem Material Twisted/Bent (2981)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

Sensor kit expiration date is 30-sept-2019.Customer's medical event occurred "2 weeks ago" from the date abbott diabetes care became aware of the event, which confirms device is beyond the useful life.Additional investigation activities are not required as the device met specification when it was released and throughout its lifespan.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The exact date that the incident occurred is unknown.The date entered is based on the customer report of "2 weeks ago", from the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered 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 bent inserter needle was reported with the use of the adc freestyle libre sensor.The customer reported experiencing symptoms of shaking and a loss of consciousness and was unable to self-treat.The customer had contact with a healthcare professional who administered an unspecified fluid via iv for the diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• 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: 12569436
• MDR Text Key: 274531031
• Report Number: 2954323-2021-86866
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160030
• 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
• Report Date: 10/04/2021

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 Expiration Date: 09/30/2019
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2021
• Initial Date FDA Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 76