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); Itching Sensation (1943); Skin Irritation (2076); Burning Sensation (2146)

Event Date 02/11/2019

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 device mfg date is unknown.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported experiencing an infection at the insertion site after a day of applying an adc freestyle libre sensor.Customer experienced symptoms described as irritation, itching and burning sensation during second week of (b)(6) 2019, and was treated with unspecified cortisone and antibiotics by the doctor at office.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(4) 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 at the insertion site after a day of applying an adc freestyle libre sensor.Customer experienced symptoms described as irritation, itching and burning sensation during second week of (b)(6) 2019, and was treated with unspecified cortisone and antibiotics by the doctor at office.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: 8386995
• MDR Text Key: 137714859
• Report Number: 2954323-2019-01840
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599000202
• UDI-Public: 00357599000202
• 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: 05/01/2019

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 Model Number: 71702-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/04/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2019
• 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: 42 YR
• Patient Weight: 64