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

Model Number 71702-01

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 02/25/2018

Event Type  Injury  

Manufacturer Narrative

The customer's products have been requested for investigation.A follow-up report will be filed once the meter is returned or additional information is obtained.The actual date when the event occurred in unknown.The date listed is the date when abbott diabetes care became aware of the event.The date of manufacture is unknown.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care received an email posting that reported the following information related to the customer¿s adc freestyle libre sensor.¿accuracy is the problem.I¿ve tried it, and they put me in the hospital for a wrong number¿.No additional information was provided and there is no way to gather any further information from the customer.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The reported complaint does not pertain to the freestyle libre reader.Therefore no further investigation into the reader will be required.Dhrs (device history review) for all fs libre sensors within expiration at the time of complaint were reviewed and the dhr review showed no there were no deviations from the validated manufacturing process.Clinical data was reviewed and confirmed that fs libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for fs libre sensors was reviewed and showed no anomalies or non-conformances that could lead to the complaint.A tripped trend review was for the reported complaint and fs libre sensors, no tripped trends were observed.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

Abbott diabetes care received an email posting that reported the following information related to the customer¿s adc freestyle libre sensor.¿accuracy is the problem.I¿ve tried it, and they put me in the hospital for a wrong number¿.No additional information was provided and there is no way to gather any further information from the customer.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 7375954
• MDR Text Key: 103649629
• Report Number: 2954323-2018-02445
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention