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	01/14/2019
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
The customer reported that while charging their freestyle libre reader, the usb charging cable was burned.Customer further reported it burned her usb port on her computer and affected the reader giving her an error message.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
The reader was returned.Visual inspection has been performed on the reader and no issues were observed.The charger cable has not been returned.The reader powered on with button depression and strip insertion.The reader was able to activate with a known good sensor.The reader self-test and power consumption test were performed and were within specification.The reader's battery was measured and was found to be within specification.The returned battery was charged normally.Reader was connected to a computer, no issue was observed with reader or the computer port.No malfunction or product deficiency was identified.
Event or Problem Description
The customer reported that while charging their freestyle libre reader, the usb charging cable was burned.Customer further reported it burned her usb port on her computer and affected the reader giving her an error message.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: 8285968
• Report Number: 2954323-2019-00837
• Device Sequence Number: 16787998
• Product Code: PZE
• UDI-Device Identifier: 00357599000219
• UDI-Public: 00357599000219
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/09/2019

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: 02/19/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR