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

Model Number 71702-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994); Burning Sensation (2146)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned.A follow-up report will be filed if product is returned or additional information is obtained.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

Customer reported experiencing an infection while wearing an adc freestyle libre sensor, after 4-days of wear.He further reported that on (b)(6) 2018 he noticed ¿burning and pain¿ at the insertion site.On (b)(6) 2018 customer had contact with a healthcare provider and was prescribed bactrim (sulfamethoxazole and trimethoprim), an antibiotic.No additional treatment was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.The adhesive was returned with the sensor puck.Extended investigation has also been performed.Dose audit reports and environmental monitoring reports, including bioburden and endotoxin testing, were reviewed for the quarterly period during which each complaint unit was manufactured.No abnormalities were found, and the investigation showed all processes were effective.No malfunction or product deficiency was identified.

Event Description

Customer reported experiencing an infection while wearing an adc freestyle libre sensor, after 4-days of wear.He further reported that on (b)(6) 2018 he noticed ¿burning and pain¿ at the insertion site.On (b)(6) 2018 customer had contact with a healthcare provider and was prescribed bactrim (sulfamethoxazole and trimethoprim), an antibiotic.No additional treatment was reported.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
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 8254034
• MDR Text Key: 133255833
• Report Number: 2954323-2019-00482
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599001018
• UDI-Public: 00357599001018
• 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,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2018
• 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: 55 YR
• Patient Weight: 73