MAUDE Adverse Event Report: OMRON (DALIAN) CO., LTD. (PLANT 1) ADVANCED BLOOD PRESSURE MONITOR

Model Number BP765

Device Problem High Readings (2459)

Patient Problems Abrasion (1689); Abscess (1690); Cellulitis (1768); Fall (1848); Hematoma (1884); Syncope/Fainting (4411)

Event Date 08/01/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the end user reported that the consumer (user) had been using omron blood pressure monitors for years.The latest model she was using was bp765.Her blood pressure medication was adjusted based on the information that she gave to her internal medicine doctor.Between august and september the consumer had four falls that were attributed to her being on too much blood pressure medication.During one of the consumer's falls, she sustained a cut that turned into cellulitis then turned into an abscessed hematoma that required surgery.The consumer was hospitalized in september and october for the surgery.She continued to follow-up with her internal medicine doctor and provided two blood pressure readings each day.During her appointment on (b)(6) 2021, the consumer's blood pressure was 121/74, which was much lower than the readings she was getting at home.Her doctor told her to bring her blood pressure monitor to the office on (b)(6) 2021.The systolic readings between the consumer's blood pressure monitor and the hospital monitor were the same; however, there was a seventeen point difference between the diastolic readings.The consumer believed that she was overmedicated due to her faith in her blood pressure monitor, which led to her falls and other problems.When she talked to a representative she was told the monitors were only warranted for five years.The consumer stated she thought the warning to replace the blood pressure monitor every five years should be placed prominently on the machine.She would have gladly replaced her unit rather than go through the falls, hospitalizations, and surgery.She did not believe she had her blood pressure monitor for five years, but she no longer had the receipt or packaging to prove it.She stated she would no longer rely on omron blood pressure monitors as she had in the past.During a follow-up call, the consumer stated her unit was reading high.She has had issues with her blood pressure ever since she was young, and she had gastric bypass in (b)(6).As she was losing weight, the consumer would monitor her blood pressure twice a day.The consumer's internal medicine doctor changed her medication based on her omron unit readings when she had visited two different times.From (b)(6) to (b)(6), the consumer would get readings like 163/98, but when she took a reading at the doctor's, it was 17 points less.She normally took her readings from her omron unit to her doctor's office.When she took a reading she would be sitting at her kitchen table with her feet flat on the floor.She applied the cuff snug and used her right arm due to having her lymph nodes removed.Her arm size was 14".She was the only user.She took her readings once a day until recently when her doctor wanted her to take them twice a day.She used the original cuff.She believed the cuff would inflate over 200.The highest she recalled was 212.She only used the batteries, not the power cord.The batteries she used were (b)(6).She had fallen four times in a period of four months.Due to the falls, she was admitted twice.Once in (b)(6) for 2 days where she had a ct scan and echocardiogram.Another time was in (b)(6) for 3 days due to her oxygen being low.She also received some scrapes on her knees and was passing out.The doctor determined she was on way too many blood pressure medications, and he removed two of her medications.She had not fallen since.The consumer's husband drove her both times she went to the er and was admitted.She has another appointment on the (b)(6).The consumer preferred the cuff style she was currently using.She loved the unit.A replacement bp5450 was being sent to the consumer.

Manufacturer Narrative

Updated information added to section d9 and h10.Updated f3-5 with new address.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.A postage paid label was sent to retrieve the unit for further investigation.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 lcd display had partial blurred numbers; otherwise, the unit and cuff was working within specifications.As a result, the unit and cuff were determined to be conforming.Further investigation into the cause was considered since the consumer had stated the unit was reading higher than the doctor's unit by 17 mmhg.Blood pressure is changing from moment to moment.Well-known fluctuations include fluctuations during a single day and day·to·day fluctuations.Also known are weekly fluctuations, and seasonal fluctuations that are high in cold winters and low in hot summers.There are individual differences in the range and pattern of these blood pressure fluctuations.The measurement method is also described in the instruction manual.Blood pressure was measured with the returned product and a sample product, and the results were compared.There was no significant difference.The measurement was performed by 5 persons, 5 times per person with each bpm (measured alternately once), and the average values of each person were compared.The reason why the lcd was partially dimmed is that the signal reached the ito terminal of the lcd, so it is judged that some kind of failure occurred inside the lcd; however, the cause of the internal failure of the lcd could not be identified.Although the display is partially faint, the numbers can be confirmed, so it is judged that the measurement results will not be misread.Since there was no issue found with returned device; correction is not necessary.

Event Description

On december 7, 2021, the end user reported that the consumer (user) had been using omron blood pressure monitors for years.The latest model she was using was bp765.Her blood pressure medication was adjusted based on the information that she gave to her internal medicine doctor.Between (b)(6) the consumer had four falls that were attributed to her being on too much blood pressure medication.During one of the consumer's falls, she sustained a cut that turned into cellulitis then turned into an abscessed hematoma that required surgery.The consumer was hospitalized in (b)(6) for the surgery.She continued to follow-up with her internal medicine doctor and provided two blood pressure readings each day.During her appointment on (b)(6) 2021, the consumer's blood pressure was 121/74, which was much lower than the readings she was getting at home.Her doctor told her to bring her blood pressure monitor to the office on (b)(6) 2021.The systolic readings between the consumer's blood pressure monitor and the hospital monitor were the same; however, there was a seventeen point difference between the diastolic readings.The consumer believed that she was overmedicated due to her faith in her blood pressure monitor, which led to her falls and other problems.When she talked to a representative she was told the monitors were only warranted for five years.The consumer stated she thought the warning to replace the blood pressure monitor every five years should be placed prominently on the machine.She would have gladly replaced her unit rather than go through the falls, hospitalizations, and surgery.She did not believe she had her blood pressure monitor for five years, but she no longer had the receipt or packaging to prove it.She stated she would no longer rely on omron blood pressure monitors as she had in the past.During a follow-up call, the consumer stated her unit was reading high.She has had issues with her blood pressure ever since she was young, and she had gastric bypass in february.As she was losing weight, the consumer would monitor her blood pressure twice a day.The consumer's internal medicine doctor changed her medication based on her omron unit readings when she had visited two different times.From (b)(6), the consumer would get readings like 163/98, but when she took a reading at the doctor's, it was 17 points less.She normally took her readings from her omron unit to her doctor's office.When she took a reading she would be sitting at her kitchen table with her feet flat on the floor.She applied the cuff snug and used her right arm due to having her lymph nodes removed.Her arm size was 14".She was the only user.She took her readings once a day until recently when her doctor wanted her to take them twice a day.She used the original cuff.She believed the cuff would inflate over 200.The highest she recalled was 212.She only used the batteries, not the power cord.The batteries she used were duracell.She had fallen four times in a period of four months.Due to the falls, she was admitted twice.Once in september for 2 days where she had a ct scan and echocardiogram.Another time was in october for 3 days due to her oxygen being low.She also received some scrapes on her knees and was passing out.The doctor determined she was on way too many blood pressure medications, and he removed two of her medications.She had not fallen since.The consumer's husband drove her both times she went to the er and was admitted.She has another appointment on the 21st.The consumer preferred the cuff style she was currently using.She loved the unit.A replacement bp5450 was being sent to the consumer.

• Brand Name: ADVANCED BLOOD PRESSURE MONITOR
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON (DALIAN) CO., LTD. (PLANT 1); no. 3 songjiang rd., economic; technical development zone; dalian, 11660 0; CH 116600
• MDR Report Key: 13030763
• MDR Text Key: 286457565
• Report Number: 1450057-2021-00007
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: BP765
• Device Catalogue Number: BP765
• Device Lot Number: 201505LG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2021
• Distributor Facility Aware Date: 12/07/2021
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 12/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female