MAUDE Adverse Event Report: ONBO ELECTRONIC (SHENZHEN) CO. LTD. RELION; AUTOMATIC BLOOD PRESSURE MONITOR

Model Number BP3UP1-1A

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Fall (1848); Pain (1994); Loss of consciousness (2418); Tooth Fracture (2428)

Event Date 12/26/2017

Event Type  Injury  

Event Description

(b)(6) claims the blood pressure monitor consistently read around 160/98-102 for him on multiple occasions.On (b)(6) 2017, (b)(6) measured his blood pressure with the monitor and obtained a similar measurement again.On the instruction of his doctor, he was to take an extra ½ dose of his medication if his readings were high.(b)(6) took the extra ½ dose and claimed he felt fine.Later that day, around 7:30 pm (time of previous drug administration not given), (b)(6) prepared supper and moved to the living room to eat.(b)(6) claims he placed the supper plate down onto a glass topped table (coffee table/side table), and that was the last thing he remembered until he woke up lying on the floor.(b)(6) believes he was unconscious for approximately 20 minutes.In falling, (b)(6) had also broken his glass topped table of which gave a small cut to his shirt and finger.(b)(6) also had a sore jaw and some teeth that felt loose after his fall that he attributes to possibly hitting his jaw on the floor or table when falling.(b)(6) had not claimed any issue with eating or teeth (other than feeling loose) the multiple times he discussed the complaint with us since the incident.(b)(6) visited his doctor on (b)(6) 2017, with his blood pressure monitor.Repeated measurements of the monitor while at the doctor's office, demonstrated the unit was repeatedly measuring in the 168/102 range while the doctor's equipment measured around 115/60; no specific method of comparison was stated.The doctor commented that the monitor was not accurate and (b)(6) agreed.Initial information of the incident was received on jan 6, 2018.The subject device had already been returned to the store of purchase.The store could not locate the specific device when follow-up was performed.(b)(6) visited his dentist on (b)(6) 2018, and supplied data regarding the visit later that day.(b)(6) had new information that multiple teeth were damaged worse than he initially thought, and many were recommended for extraction resulting in his future need of dentures.

• Brand Name: RELION
• Type of Device: AUTOMATIC BLOOD PRESSURE MONITOR
• Manufacturer (Section D): ONBO ELECTRONIC (SHENZHEN) CO. LTD.; no 497, ta laneg nan road; ta laneg street, baoan distric; shenzhen, guangdong ; CH
• MDR Report Key: 7322629
• MDR Text Key: 101835176
• Report Number: 3003331014-2018-00001
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00605388043863
• UDI-Public: (01)00605388043863(10)UNKOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 03/05/2018,03/07/2018

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: BP3UP1-1A
• Device Catalogue Number: 736792
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2018
• Device Age: 1 MO
• Event Location: Home
• Date Report to Manufacturer: 03/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 87