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 Code	Skin Irritation (2076)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is an initial final report.This issue does not meet reportability criteria, however it is being reported to fda as the complaint was received via user report.If product is returned, this case will be re-opened, an investigation will be conducted, and a follow-up report will be submitted after all investigation activities are complete.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Abbott diabetes care received a mhra user report about a us customer which reported the following information: the customer experienced an adverse skin reaction with symptoms described as rashes and scars while wearing an adc freestyle libre sensor.Additional information received from the customer who further reported experiencing irritation and has scheduled an appointment with the doctor for the next week.No treatment was reported.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The reported sensor was returned and investigated.Visual inspection was performed on the sensor and no issues were observed.The adhesive was returned and the adhesive came off.Extended investigation has been performed for the reported complaint.Dose audit reports and environmental monitoring reports, including bioburden and endotoxin testing, were reviewed and no abnormalities were found.The investigation showed all processes were effective.No product deficiency was identified.
Event or Problem Description
Abbott diabetes care received a mhra user report about a us customer which reported the following information: the customer experienced an adverse skin reaction with symptoms described as rashes and scars while wearing an adc freestyle libre sensor.Additional information received from the customer who further reported experiencing irritation and has scheduled an appointment with the doctor for the next week.No treatment was reported.There was no report of death or permanent impairment 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: 8313408
• Report Number: 2954323-2019-01112
• Device Sequence Number: 11334831
• Product Code: PZE
• UDI-Device Identifier: 00357599000202
• UDI-Public: 00357599000202
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,foreign
• 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: 01/30/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 02/06/2019
• 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