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 Diabetic Ketoacidosis (2364); Coma (2417); Loss of consciousness (2418)

Event Date 07/09/2021

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 mfg 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

A twisted filament issue was reported with the adc freestyle libre sensor.A healthcare professional reported that the customer¿s sensor had a twisted filament issue and as a result, the customer was unable to obtain sensor scans.Consequently, the customer experienced a loss of consciousness and went into a diabetic coma.It was further reported the customer was hospitalized from (b)(6) 2021 to (b)(6) 2021 for the diagnosis of diabetic ketoacidosis however, no treatment details were provided.There was no report of death or permanent injury associated with this event.

Event Description

A twisted filament issue was reported with the adc freestyle libre sensor.A healthcare professional reported that the customer¿s sensor had a twisted filament issue and as a result, the customer was unable to obtain sensor scans.Consequently, the customer experienced a loss of consciousness and went into a diabetic coma.It was further reported the customer was hospitalized from (b)(6) 2021 to (b)(6) 2021 for the diagnosis of diabetic ketoacidosis however, no treatment details were provided.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 and an extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A valid serial number has not been provided.A tripped trend review was completed for the libre sensor and reported complaint and it concluded that the tripped trend was not correlated with any identified product related issue.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.

• 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: 12347467
• MDR Text Key: 267429614
• Report Number: 2954323-2021-81088
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention