MAUDE Adverse Event Report: OMRON HEALTHCARE, INC. OMRON BLOOD PRESSURE MONITOR; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number BP652N

Device Problem Low Readings (2460)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 07/05/2022

Event Type  malfunction  

Event Description

I have two omron wrist-style bp monitors.I track my bp regularly and the monitors report it to be within acceptable limits.On (b)(6) 2022 i had a medical appointment.I wrist-style device (mfg unknown) showed a significantly elevated bp.I later checked my bp at home with both of my wrist units.Each reported an acceptable level.I then secured my wife's omron arm cuff unit that reported a very significantly higher bp than the wrist units.I checked the discrepancy several times and it appeared that the wrist units are terribly flawed.My concern is that i have tried to be diligent in checking my bp but these units are reporting inaccurately measuring and reporting bp upon which i have relied to my detriment.I have sought omron's help.They now want me to send the units to them for "testing." fda safety report id# (b)(6).

• Brand Name: OMRON BLOOD PRESSURE MONITOR
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): OMRON HEALTHCARE, INC.
• MDR Report Key: 15003026
• MDR Text Key: 295905574
• Report Number: MW5110823
• Device Sequence Number: 1
• 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: 07/08/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BP652N
• Device Catalogue Number: BP652N
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White