MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE PRECISION PRO; BLOOD GLUCOSE TEST STRIPS

Model Number	71284-70
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is an initial final report. this issue does not meet reportability criteria; however it is being reported to fda as the complaint was received via user report.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Abbott diabetes care received a medwatch report which contained the following information: a healthcare professional reported that "the blood glucose test strip are reading wet/damage".No further information was provided.There was no report of any medical event or third-party medical intervention.Based on the information provided, there was no report of serious injury associated with this event.

• Brand Name: FREESTYLE PRECISION PRO
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 12084415
• Report Number: 2954323-2021-74188
• Device Sequence Number: 17010651
• Product Code: NBW
• UDI-Device Identifier: 00093815712848
• UDI-Public: 00093815712848
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K132511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71284-70
• Device Catalogue Number: 71284
• Device Lot Number: 89C1P0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1