MAUDE Adverse Event Report: OMRON HEALTHCARE CO., LTD OMRON PLATINUM CONNECTED UPPER ARM BLOOD PRESSURE MONITOR

Model Number	BP5450
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Fall (1848); Concussion (2192); Loss of consciousness (2418); Tooth Loss (4831)
Date of Event	08/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A postage label has been sent for retrieval of the home unit for inspection.A replacement unit was sent to the consumer a root cause has not been determined.It has not been confirmed if the device caused or contributed to the reported incident; however, due to the customer reporting having fainted, being concussed, lost teeth, and being hospitalized this medwatch is being filed.The product instruction manual includes following warnings: this device is not intended to be a diagnostic device.Consult your physician before using the device for any of the following conditions: common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases.
Event or Problem Description
The consumer had stated that her reading were high at 180/110, when compared to her doctors reading which had been 150/80.Based on her readings from her unit her doctor had increased her medication.Caller states had a severe fall and was hospitalized due to being over medicated.During follow-up call with omron representative, consumer stated that on (b)(6) 2022 she had a terrible fall, due to being over medicated.The consumer had explained that during the fall, she had lost teeth, she had a concussion and she had been hospitalized.The consumer had stated that she is the only person using the unit.She had also stated her arm is 16 1/2 inches.The consumer had explained that she had never had problem with her readings at the doctor's office; she had stated the readings had always been normal.Omron customer service representative advised consumer stop using the unit and not adjust medication based on the measurement results from the home blood pressure monitor.Consumer was advised that only physician is qualified to diagnose and treat high blood pressure.
Additional Manufacturer Narrative
After initial report was submitted, the consumer returned the unit back to importer for evaluation.The importer evaluated the returned unit and it passed evaluation.Then, the returned unit was sent to device manufacturer for further testing.Here is the summary of the manufacturer device investigation: the unit was tested and unit was working within specifications.Therefore, the consumer returned product was judged a conforming product.Further investigation in to cause was considered since the consumer had stated the unit was reading high compared to their doctor's unit.The deflation test, leakage test, and accuracy test were conducted on the returned unit.The results were all conforming.The returned unit and cuff were tested for blood pressure measurement along with a sample blood pressure monitor and cuff.There was no significant difference in the measurement result when four people tested the units 3 times.It is suggested based on the results that the reason for high readings is likely due to daily fluctuations, the consumer's body, and the measurement method.The manufacturer reviewed the qa test data, post market data/complaint history for similar issues.No issue/problem was noted during data reviewed by the manufacturer.The risk analysis document was reviewed and it was determined that no update to risk management documents is required.Since there was no issue found with returned device, further investigation and correction is not necessary.

• Brand Name: OMRON PLATINUM CONNECTED UPPER ARM BLOOD PRESSURE MONITOR
• Common Device Name: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON HEALTHCARE CO., LTD; 53 kunotsubo; terado-cho; muko-city, kyoto 61700 02; JA 6170002
• Manufacturer (Section G): OMRON HEALTHCARE CO., LTD; 53 kunotsubo; terado-cho; muko-city, kyoto 61700 02; JA 6170002
• Manufacturer Contact: tomoji zukawa ; 53 kunotsubo; terado-cho; muko-city, kyoto 61700-02 ; JA 6170002
• MDR Report Key: 16274095
• Report Number: 8030245-2023-00001
• Device Sequence Number: 5925311
• Product Code: DXN
• UDI-Device Identifier: 00073796265458
• UDI-Public: (01)00073796265458
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: Lay User/Patient
• Device Model Number: BP5450
• Device Catalogue Number: BP5450
• Device Lot Number: 202201V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female