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

Model Number BP652N

Device Problem High Readings (2459)

Patient Problem No Code Available (3191)

Event Date 03/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Consumer was advised to proper cuff application and proper body position when taking bp measurements by the call center agent.During troubleshooting with the call center agent, consumer received a bp reading of 124/70.Consumer indicated that is a normal reading for him.In addition, during follow-up call, consumer had stated he noticed the unit reading high about 2 weeks ago when he was "under stress" consumer indicated that his blood pressure was still high when he got to the hospital so he was admitted both times for high blood pressure.Consumer was advised to stop using the unit.A postage paid label was sent to retrieve the unit for further investigation and verbal request for unit return was made.The u.S.Importer is requesting manufacture of the device to further investigate this incident.A root cause has not been determined.It has not been confirmed that the blood pressure monitor provided an inaccurate result or if the device caused or contributed to the reported incident.However, due to the need for medical intervention and in an abundance of caution, this medwatch is being filed.

Event Description

Consumer reported bp monitor is reading 40 points higher than bp786 monitor.He is taking readings 3 minutes apart; two readings daily.Consumer wanted compensation for the unit.Consumer claimed that he went to emergency room (er) twice because of high readings, two weeks ago; on friday and saturday.Consumer reported 1st time he was admitted for 6 hours and 2nd time for 2 to 3 hours.Consumer claimed he received an ekg and chest x-ray the 1st time he visited.At the er, he was given a new blood pressure medication.The unit is reading 40 to 60 points higher.He is sitting at a desk to take readings.He is putting the face of the monitor on the outside of the wrist.Consumer reported he is not going to send anything back and he is going to lawsuit if omron does not help him.Consumer was advised to proper cuff application and proper body position when taking bp measurements by the call center agent.During troubleshooting with the call center agent, consumer received a bp reading of 124/70.Consumer indicated that is a normal reading for him.Consumer was advised to stop using the unit.A postage paid label was sent to retrieve the unit for inspection.During follow-up call, consumer stated he purchased the unit 6 months ago, he noticed the unit reading high about 2 weeks ago when he was "under stress".He went to er 2 times in the same weekend due to high readings.His blood pressure was still high when he got to the hospital so he was admitted both times for high blood pressure.He will not return the unit because he is going to file a claim against omron for his medical bills.Consumer indicated he does not want a new unit or refund.Consumer disconnected the call.On (b)(6) 2016, consumer sent an email.In email the email consumer wrote bp652 produced wildly inaccurate systolic results from 50 to 70 points higher than actual readings from omron arm bp unit.Three weeks ago, he went to er twice in one weekend, for bp readings systolic over 240.He has taken photos of device producing highly inaccurate readings when compared to other omron monitor.His systolic pressure over 247 approximately twenty minutes before entering the emergency room.He has several other reading over systolic pressure way over 200 saved on the device on the days of the two visits to the er.The device is defective and has caused him great psychological and financial harm.It was very frightening for him to be admitted to the er for bp so high he thought he was going to die.In fact, because of the experience, he has suffered possible kidney damage.His kidney function has been very stable at 58 gfr for 10 years or more.After the "life threatening" incident, his gfr dropped to 44 and dropped further to 38 gfr.His personal physician suspects that the kidney damage was caused by an "acute" incident.They both suspect that it was because of the two er visits.He is diabetic and his blood sugar rose and of course blood pressure rose - he was literally scared to death.

Manufacturer Narrative

(b)(4).Verbal requests were made to retrieve the unit.In addition, postage paid labels were sent to retrieve the unit back for inspection.However, the end-user consumer did not return the home blood pressure monitor for inspection.The device was not received for evaluation; therefore, a device analysis could not be completed.The manufacturer reviewed the device history record, qa test data, and risk analysis, complaint history for the model number and similar models and complaint records for similar issues.No issue/problem was noted during data reviewed by the manufacturer.All risk mitigations, warnings and cautions are still correct, and in place.No further investigation required.

• Brand Name: OMRON WRIST BLOOD PRESSURE MONITOR
• Type of Device: OMRON AUTOMATIC BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON (DALIAN) CO., LTD. (PLANT 1); no. 3 songjiang rd., economic; technical development zone; dalian, liaoning 11660 0; CH 116600
• Manufacturer (Section G): OMRON (DALIAN) CO., LTD. (PLANT 1); no. 3 songjiang rd., economic; technical development zone; dalian, liaoning 11660 0; CH 116600
• Manufacturer Contact: renee thornborough ; omron healthcare, inc.; 1925 w field court, suite' 100; lake forest, IL 60045-4824 ; 8472475626
• MDR Report Key: 5598760
• MDR Text Key: 43355655
• Report Number: 3001373226-2016-00001
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

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: BP652N
• Device Catalogue Number: BP652N
• Device Lot Number: 20151014969LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/15/2016
• Device Age: 5 MO
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR