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

Model Number	71525-01
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
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 charging their freestyle libre reader, the "reader was extremely hot and the data cable started to melt and gave a smokey smell".There was no report of death, serious injury or mistreatment associated with this event.
Additional Manufacturer Narrative
The reported reader and charging cable were returned and investigated.Visual inspection was performed, and no signs of misuse were observed for the reader.However, the charging cable showed visible signs of damage.Extended investigation has also been performed for the returned reader and no abnormalities were observed.The reader self-test and power consumption test were performed and were within specification.The reader¿s battery measured at 4.08v (within normal battery voltage range).The returned battery was placed on charge and measured to be 4.16 v (within normal battery voltage range).This indicates the battery charges and discharges normally.No burn marks or abnormalities were observed on the pcba (printed circuit board assembly) of the reader indicating that smoke or fire could not have been produced from the reader.In addition, a dhr (device history review) for the reader was reviewed and the dhr showed that no issues were observed on the reader prior to release.All manufacturing tests passed and were within specification prior to release.
Event or Problem Description
Customer reported while charging their freestyle libre reader, the "reader was extremely hot and the data cable started to melt and gave a smokey smell".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: 8975342
• Report Number: 2954323-2019-06901
• Device Sequence Number: 16221152
• Product Code: PZE
• UDI-Device Identifier: 00357599000981
• UDI-Public: 00357599000981
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/05/2019

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: 71525-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1