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U.S. Department of Health and Human Services

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

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OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR Back to Search Results
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.
 
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Brand NameOMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR
Type of DeviceBLOOD 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
Manufacturer (Section G)
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
Manufacturer Contact
renee thornborough
1925 w field court
suite 100
lake forest, IL 60045-4824
8472475626
MDR Report Key7698695
MDR Text Key114333961
Report Number3006852037-2018-00001
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133379
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
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 Received07/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBP710N
Device Catalogue NumberBP710N
Device Lot Number20170109338VG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/26/2018
Device Age17 MO
Event Location No Information
Date Manufacturer Received09/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/18/2018 Patient Sequence Number: 1
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