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

Model Number 71940-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fainting (1847); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 07/22/2019

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 is the date reported by the customer as "(b)(6) 2019 - (b)(6) 2019." the device mfg 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 customer reported the adc freestyle libre sensor detached on day 5 of wear due to being fainting and the sensor being"bumped against something." on (b)(6) 2019 or (b)(6) 2019, while on vacation in (b)(6), the customer lost consciousness.An hcp obtained a blood glucose of 51 mg/dl on an unspecified meter and provided the customer with a "cola and 3 spoons of jam and glucose" as a treatment for hypoglycemia.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and an extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

A customer reported the adc freestyle libre sensor detached on day 5 of wear due to being fainting and the sensor being"bumped against something." on (b)(6)2019 or (b)(6)2019, while on vacation in (b)(6), the customer lost consciousness.An hcp obtained a blood glucose of 51mg/dl on an unspecified meter and provided the customer with a "cola and 3 spoons of jam and glucose" as a treatment for hypoglycemia.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: tara williamson ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644472
• MDR Report Key: 8945375
• MDR Text Key: 155981390
• Report Number: 2954323-2019-06691
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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 Age: 70 YR
• Patient Weight: 79