MAUDE Adverse Event Report: WALGREENS WALGREENS 960BT SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE

Model Number WGNSPS-960BT

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2019

Event Type  malfunction  

Event Description

I purchased the walgreens blood pressure monitor 960bt. This is a bluetooth device that is supposed to connect to an ios device, using (b)(6) connect app. Trying to connect this to my phone or ipad the app says device not supported even though the app has this as a product that it supports. I checked online and this has been going on since (b)(6) of 2018.

• Brand Name: WALGREENS 960BT
• Type of Device: SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE
• Manufacturer (Section D): WALGREENS
• MDR Report Key: 8381859
• MDR Text Key: 137804601
• Report Number: MW5084531
• Device Sequence Number: 0
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/28/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: WGNSPS-960BT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage