MAUDE Adverse Event Report: ABBOTT LABORATORIES / ABBOTT DIABETES CARE INC. READER FREESTYLE LIBRE; CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE

Model Number	71525-D1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Re: abbott laboratories freestyle libre: abbott lab's platform's characters numerical restriction does not allow for a full explanation of all the due diligence steps taken by me to make this contraption work; should not need a theoretical math ph.D to make this work; i am recommending that your quality assurance mds take a second look at this device.Fda safety report id# (b)(4).

• Brand Name: READER FREESTYLE LIBRE
• Common Device Name: CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE
• Manufacturer (Section D): ABBOTT LABORATORIES / ABBOTT DIABETES CARE INC.
• MDR Report Key: 9086937
• Report Number: MW5089894
• Device Sequence Number: 2802725
• Product Code: PHV
• UDI-Device Identifier: 00357599000219
• UDI-Public: 0100357599000219
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/20/2020
• Device Model Number: 71525-D1
• Device Lot Number: 04Y355D
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2019
• Patient Sequence Number: 1
• Patient Age: 67 YR