MAUDE Adverse Event Report: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR

Model Number BP710N

Device Problem High Readings (2459)

Patient Problem Loss of consciousness (2418)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A postage paid label was sent to retrieve the unit for further investigation and verbal requests for unit return was made.Replacement unit was sent to customer to facilitate the retrieval of the unit for further investigation.The u.S importer is requesting the manufacturer of the device to further investigate this incident.The instruction manual for the home unit (model bp710n) has following warnings for the consumers: "do not adjust medication based on measurement results from this blood pressure monitor.Take medication as prescribed by your physician.Only a physician is qualified to diagnose and treat high blood pressure." and "the monitor is not intended to be a diagnostic device." a root cause has not been determined.It has not been confirmed that the blood pressure monitor 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

In the previous contact with omron via phone call on (b)(6) 2018, the consumer claimed that the unit is reading high 178/80 and his normal bp reading is 121/73.The consumer stated he was sitting at the end of the bed and had the cuff applied correctly on his left arm.He is the only user and uses the unit 1 time per day.He is using new batteries and the original cuff.The consumer has diabetes.The consumer was provided information on proper body positioning and cuff application.He got a blood pressure reading of 168/82.Consumer was provided instructions for sending the unit back for further investigation.The consumer sent an email on (b)(6) 2018 stating that he had called because his blood pressure (bp) monitor was not reading right and was he told to send the bp monitor back before he can get replacement unit.The consumer wrote that he is on bp medications and that he takes his medication according to his bp readings.He cannot be without the unit and his life depends on the unit.In the email, the consumer claimed to be upset about omron's replacement policy and threatened to get the word out to the other users; so they would think twice before purchasing an omron unit.Consumer service reached out to the user via email.In the follow-up email received on the same day ((b)(6) 2018), the consumer claimed he was in the hospital because his bp was low.He said he was probably taking bp medication when the machine was telling him it was high and it was probably low, so he passed out and was rushed to the hospital.He had 178/86 bp readings on the unit and his bp readings were 121/82 at the fire station today ((b)(6) 2018).The consumer wrote that sending the label to him to retrieve the unit back is great but he is still being without a machine.Another contact was made by the customer service representative on 06/26/2018 to get additional information from the consumer.The consumer stated that he was rushed to the er because the unit was giving high readings and he kept taking his medication.The consumer was advised not to adjust the medication off the readings by the customer service representative.Consumer claimed he was rushed to the er on (b)(6) 2018 after he passed out from low blood pressure.He was admitted to the hospital for 5 days after visiting the er for critical low blood pressure.He was advised to continue use of the monitor and base the medication on saturday (b)(6) 2018.Consumer stated he had a stress test, ultra sound of the neck and arteries and a tilted blood pressure test.His primary doctor was treating him for high blood pressure and advised him to take the medication prescribed if the monitor read over 130.His arm size is 14 inches.Consumer claimed the unit has been has been reading high for the last month out of the 6 months he has been using the unit.His normal bp while recently in the hospital has been 95-120 / 60-70.He has diabetes and no other health conditions.He uses the left arm and is able to fit 2 fingers under the cuff.The consumer was advised of the proper cuff application and his readings for his left arm was 157/86 and the right arm was 160/93.The unit inflated to 182 for the right arm reading.There was no change in medication at the er.The consumer was advised to discontinue using the bp monitor and not to base his medication on the readings of the omron unit.The consumer did not want to be without the unit and requested a replacement unit as soon as possible.The consumer was sent a postage paid label to retrieve the unit.The quality analyst reached out to consumer again on 06/27/2018 in order to obtain additional information.The consumer claimed the unit caused him to go to the er on (b)(6) 2018.His unit was reading in the 150s compared to the er reading which was 95.He was admitted for 5 days because his blood pressure was so low, and his doctor wanted to find out why his blood pressure was so low.The consumer stated they ran tests and he is on bp medication.A postage paid label has been sent for retrieval of the home unit for inspection.The consumer was advised to return the unit for inspection and a replacement unit was sent.The quality department contacted the consumer again on 07/05/2018.The consumer confirmed he has been diagnosed with hypertension for years.When asked if had seen his doctor and what his readings were at the doctor's office prior to going to the hospital, the consumer refused to answer.He indicated that he has already provided all the information and hung up.

Manufacturer Narrative

Exemption number: e2013029.Omron healthcare inc.(importer) is submitting the report on behalf of omron healthcare manufacturing vietnam co., ltd., (manufacturer).Registration no: (b)(4).Additional information added to section date rec¿d by mfr, pma/510k, type of reportable event, if follow-up, what type, and device evaluated by mfr.The manufacturer reviewed the device history records, qa test data and risk analysis, complaint history for the model number and similar models and complaint records for similar issues.The shipping information was reviewed.No issue/problem was noted during data reviewed by the manufacturer.All risk mitigations, warnings and cautions are still correct, and in place.The device was not received for evaluation; therefore, a device analysis could not be completed.No further investigation required.

• Brand Name: OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.; no. 28 vsip ii, st. 2,; vietnam-singapore indus. park; hoa phu ward thu dau mot, binh duong 82000 0; VM 820000
• MDR Report Key: 7698695
• MDR Text Key: 114333961
• Report Number: 3006852037-2018-00001
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K133379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BP710N
• Device Catalogue Number: BP710N
• Device Lot Number: 20170109338VG
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/26/2018
• Device Age: 17 MO
• Date Manufacturer Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization