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

Model Number	71938-01
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested back for investigation.A follow- up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported while using their freestyle libre reader they "noticed smoke coming out of reader after charging it".Customer also reported that he threw the reader out of the car window.There was no report of death, serious injury or mistreatment associated with this event.
Additional Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint there was no indication that the product did not meet specification.Dhrs (device history review) for the libre reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.If the product is returned, the case will be re-opened, and a physical investigation will be performed.Section has been updated based on product download.
Event or Problem Description
Customer reported while using their freestyle libre reader they "noticed smoke coming out of reader after charging it".Customer also reported that he threw the reader out of the car window.There was no report of death, serious injury or mistreatment 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: 8574093
• Report Number: 2954323-2019-03569
• Device Sequence Number: 1836452
• Product Code: PZE
• UDI-Device Identifier: 00357599000219
• UDI-Public: 00357599000219
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 71938-01
• Device Catalogue Number: 71938-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1