MAUDE Adverse Event Report: OMRON (DALIAN) CO., LTD. (PLANT 1) OMRON 7 SERIES AUTOMATIC WRIST BLOOD PRESSURE MONITOR; OMRON AUTOMATIC BLOOD PRESSURE MONITOR

Model Number BP652

Device Problem Low Readings (2460)

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 01/01/2017

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.Consumer is being sent a replacement unit.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 that her blood pressure cuff is giving bad readings which almost cost her life.It is reading over 40 points too low.She just had stroke because she thought her pressure was lower than it was and cuff is less a year old.When she got to the hospital her blood pressure was 258/146.Please help she does not have money for a new unit.During follow-up call with customer service agent, the consumer stated she had stroke in (b)(6) of 2017 and she was using the unit at the time of the stroke and the unit was reading very low.She was in the hospital for a week.They did blood work, an mri, ekg, stress test and ct.Consumer stated she had a doctor's appointment and took her unit with her.The doctor received a reading of 258/146 and the unit was reading much lower at 140/95.After taking her blood pressure at the doctor's office they took her from the doctor's office to the emergency room.Consumer indicated the pharmacy has tried the unit and it is reading very low.She is using alkaline batteries and changed monthly.Consumer has diabetes, multiple scleroses and taking blood pressure medications every 2 hours.Her wrist size is 6.5".Customer service agent provided proper instruction for cuff application using left wrist and body positioning at the time of taking bp measurements.Consumer got reading of 145/91.Customer service agent advised consumer not to use the unit again and sent a postage paid label to retrieve the unit for further investigation.During follow-up call with the quality analyst, consumer stated her blood pressure unit always reads around 140.She went to a scheduled doctor's appointment in (b)(6) and the doctor got a reading of over 250.The doctor sent her to the er.They ran multiple tests and she was admitted for a week having had a stroke.Consumer stated she did not know her unit was reading low at that time.She thought the unit was working properly.She was on blood pressure medication before the stroke and she still is now.She went to another doctor's appointment this week and her readings were again up around 260 when her unit was reading 140.She is the only user.She purchased the unit 6 months ago and uses the unit every day.She would like to try to get a new unit that is arm model.Consumer stated she is fine now.Consumer was advised to send the unit for further investigation via postage paid label.

Manufacturer Narrative

(b)(4).Correction to initial report: report date - change the date from 04/09/2017 to 04/14/2017.The initial report was filled out and submitted was on 04/14/2017.Initial reporter - changed city from (b)(6).The quality analyst (qa) contacted consumer to ensure consumer had received a postage paid label and planning to return the unit for inspection.Consumer called back and indicated her address was incorrect and provide update to the address.Replacement unit was sent back to customer.Quality analyst (qa) called consumer again to inquire about returning the unit.Consumer indicated was planning to ship the unit back that day.Quality analyst called back again on 05/02/2017; consumer stated she was not able to send the unit back because had been in the hospital for the past week.Consumer stated that she had suffered another stroke.Consumer stated she will return the unit after she is released from the hospital.Quality representative called back again on 05/11/2017 and 05/23/2017.Consumer's daughter indicated unit was sent but it came back to their residence after 4 to 5 days later.Consumer stated they would send the unit again.Another postage paid label sent.As of 06/09/2017, unit has not been received after multiple attempts made to retrieve the unit.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.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.No further investigation required.The device was not received for evaluation; therefore, a device analysis could not be completed.

• Brand Name: OMRON 7 SERIES AUTOMATIC 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, 11660 0; CH 116600
• Manufacturer (Section G): OMRON (DALIAN) CO., LTD. (PLANT 1); no. 3 songjiang rd., economic; technical development zone; dalian, 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: 6493965
• MDR Text Key: 72886697
• Report Number: 3001373226-2017-00002
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042505
• 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: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BP652
• Device Catalogue Number: BP652
• Device Lot Number: 20141236442LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/05/2017
• Device Age: 2 YR
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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: 41 YR
• Patient Weight: 82