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

Model Number	71702-01
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Infection (1930); Itching Sensation (1943); Skin Irritation (2076); Burning Sensation (2146)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 8386995
• Report Number: 2954323-2019-01840
• Device Sequence Number: 277736
• Product Code: PZE
• UDI-Device Identifier: 00357599000202
• UDI-Public: 00357599000202
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P160030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 64