MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE PRECISION PRO; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	71284
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The blood glucose test strips are reading wet/damaged.

• Brand Name: FREESTYLE PRECISION PRO
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop rd.; alameda CA 94502
• MDR Report Key: 11841033
• Report Number: 11841033
• Device Sequence Number: 11677705
• Product Code: NBW
• UDI-Device Identifier: 00093815712848
• UDI-Public: (01)00093815712848
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2021
• Report Date (Section F): 04/16/2021

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: Health Professional
• Device Model Number: 71284
• Device Catalogue Number: 71284
• Device Lot Number: 89C1P0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/16/2021