MAUDE Adverse Event Report: OMRON HEALTHCARE CO., LTD. OMRON 5 SERIES UPPER ARM BLOOD PRESSURE MONITOR

Model Number	BP7250
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Renal Impairment (4499)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Postage paid label was sent to retrieve the unit for further investigation and verbal request for unit return was made.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 that ct scan caused stage 3 kidney failure and had ct scan was done due to high bp readings, this medwatch is being filed.
Event or Problem Description
Consumer reported the unit is reading high at home so did a comparison at doctor's office and it read close to 25 mmhg higher.At the doctor's office manual bp reading was done 1st on his right arm; 108/70, then on his home unit; 132/87 and after that reading was taken on his old omron unit; 132/92.Consumer was advised to allow enough time in between readings for arteries to decompress.Customer service representative provided proper instructions for cuff application.Consumer indicated high readings at home and he sites at the kitchen table and follows the directions.Consumer was informed that if the unit is retuned for inspection and if it passes inspection, it will returned back to him.Consumer got upset and stated he went to the doctor a few weeks ago because of the high readings.He had more test done.He had ct scan done.Customer service representative advised consumer not use the unit again and sent a pre-paid shipping label to retrieve the unit for further testing.Consumer reported had dye injected during the scan and found out the dye causes kidney issues and he is now in stage 3 kidney failure.He does have heart issues.Consumer normal bp range for him is 108/70 and unit has been reading 128-140/84-90.His left arm size is 14".He applies cuff ? inch above elbow, air hose in line with middle finger, cuff not snug.The cuff is applied on bare skin, sits at the table on a hard surface on straight back chair when measuring blood pressure.Consumer was provided instructions for cuff application and advised to measure his bp while on phone with agent; which he had bp measured at 136/88 pulse 67.Consumer is the only user of the bp monitor and uses twice a day.He is using adapter and alkaline batteries with the unit.During follow-up call, consumer stated the unit has been reading high on him since he got it.For him normal bp is 108/70 and unit has been reading 128-140/84-90.He is not sure though because he has nothing to compare it to.He does have a heart condition and had a stent put in 2018 for an enlarged heart.He went in about 3 weeks ago because the unit was reading high.They did a ct scan and injected him with dye for the ct.All of the testing came back normal.He just had his check up with his doctor and they took 21 vials of blood because something was off with his numbers and they were trying to figure it out.He now is in stage 3 kidney failure and he is stating that is due to the unnecessary ct scan that he had done because of omron unit reading high.Consumer requested omron send him a new unit.Customer service representative sent a new unit and requested to send his unit back for further testing.
Additional Manufacturer Narrative
A postage paid label was sent to retrieve the unit for further investigation and verbal request for unit return was made.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 that ct scan caused stage 3 kidney failure and had ct scan was done due to high bp readings, this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.After initial report was submitted, 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 to be a conforming product.The manufacturer compared the blood pressure measurement results between consumer returned product and the same model (hem-7150) and another model (hem-8712), there was no difference in the measurement results of the three units.Blood pressure is highly variable index that is affected by physical condition and time of the day.Therefore, even if the blood pressure measured at a hospital or clinic is within the normal range, it may show different values at specific time and place such as early morning, night time, or day time or at specific place other than a medical institute such as home or workplace.The instruction manual has that blood pressure varies constantly.Many factors including stress, time of day, and/or how you apply the arm cuff, may affect your blood pressure.The manufacturer reviewed the qa test data and complaint history for similar issues.No issue/problem was noted during data reviewed by the manufacturer.No issue or increasing trend was for complaint data review.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 5 SERIES 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
• MDR Report Key: 11356928
• Report Number: 8030245-2021-00002
• Device Sequence Number: 4107086
• Product Code: DXN
• UDI-Device Identifier: 00073796267254
• UDI-Public: (01)00073796267254
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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: Lay User/Patient
• Device Model Number: BP7250
• Device Catalogue Number: BP7250
• Device Lot Number: 202005V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability