MAUDE Adverse Event Report: WITHINGS S.A. BLOOD PRESSURE MONITOR CONNECT; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number	WPM05-ALL-INTER
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
I purchased the withings bpm (blood pressure monitor) connect blood pressure monitor on (b)(6) 2022.It read that i had high blood pressure fairly consistently.I saw my doctor on (b)(6) 2022.I brought the device.They confirmed that i did not have blood high blood pressure.After taking multiple readings with the device and with the doctors office equipment the device was consistently around 30 point high on systolic.I engaged withings support.They have been unhelpful, requesting that i follow directions, double check my arm circumference is in the range, get readings from other people (which also seemed inaccurate but we had no device to compare to), and is now asking for videos of me taking the blood pressure.The device is inaccurate.Looking at online reviews this seems to be a problem for around 10% of reviewers.This causes a burden on consumers to see their doctor when unnecessary or even possibly causing over medication if they are trying to monitor a known problem.Fda safety report id # (b)(4).

• Brand Name: BLOOD PRESSURE MONITOR CONNECT
• Common Device Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): WITHINGS S.A.
• MDR Report Key: 15825688
• Report Number: MW5113359
• Device Sequence Number: 5200668
• Product Code: DXN
• UDI-Device Identifier: 03700546705984
• UDI-Public: (01)03700546705984
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 11/16/2022

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: WPM05-ALL-INTER
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN, FISH OIL, MULTVITAMIN.; ATORVASTATIN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White