MAUDE Adverse Event Report: IDEAL LIFE IDEAL LIFE BLOOD PRESSURE MONITOR

Model Number BPM 0001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

The telecare management program is a service provided to qualifying individuals with a diagnosis of chf, cad, diabetes, and htn.This service is provided at no cost to the individual and is covered by their health plan in order to decrease health care costs and undesirable healthcare utilizations for a high risk population.This program provides in-home biometric monitoring equipment to qualifying participants.The equipment uses bluetooth technology to transmit biometric readings to a web portal that is monitored daily.Biometric readings that are out of range will trigger an alert in the web portal.An alert will be triggered for blood pressure readings that meet the following criteria: systolic blood pressure greater than "18 0" or less than 89, diastolic blood pressure greater than 100 or less than 54, and heart rate greater than 100 or less than 49.The biometric equipment is provided by an equipment vendor that is responsible for, but not limited to installation of the equipment, instruction on using the equipment, and troubleshooting/servicing the equipment.The blood pressure monitor provided by the equipment vendor is manufactured by ideal life ( model no: bpm 0001).The registered nurse that monitor the biometric readings in the web portal have reported numerous suspicious blood pressure readings with concerns regarding the accuracy of the blood pressure monitor.Program participants and their provider(s) (i.E.Primary care physicians, cardiologists, etc) also voiced concerns to the registered nurses involved with this program regarding the accuracy of the blood pressure monitor.Research was conducted based on the information reported to me and i gathered data regarding the claims.On 04/07/2016, i submitted the data that i found to the equipment vendor to conduct further research.Approximately 353 out of 441 participants in this program are receiving blood pressure monitoring using an ideal life blood pressure monitor.The telecare management pressure monitoring using an ideal life blood pressure monitor.The telecare management program requested that the equipment vendor replace all of the ideal life blood pressure monitors with a monitor made by a different manufacturer until further research was conducted.Approximately 43 participants were identified with suspicious blood pressure readings and this was based on the research that i provided to the vendor as well as a query conducted by the vendor.The query conducted by the equipment vendor looked for participants with the following criteria: diastolic blood pressure readings over 105; participant reporting as asymptomatic; participant not showing any signs of heart rate and/or systolic blood pressure elevation.On (b)(6) 2016, a registered nurse with a caseload of approximately 50 participants reported that she noticed an increase in blood pressure alerts from participants that rarely had blood pressure alerts in the past.Many participants in the telecare management program have taken their ideal life blood pressure monitor to their physician's office to compare with the blood pressure monitor at the office.The diastolic blood pressure readings at the physician offices were 30-40 points lower on average when compared with the ideal life blood pressure monitor.One participant reported the following data after a follow-up appointment with his doctor: arm ideal life bp monitor doctor's office bp monitor right 151/105 136/78 left 139/101 146/88.The registered nurse that works with this program participant spoke with a nurse at the doctor's office.The nurse states "we believe the equipment is providing falsely elevated readings and request that the blood pressure monitor be serviced and/or replaced." the participants blood pressure monitor was replaced approximately 3-4 times with ideal life blood pressure monitors, but the issue did not resolve.This participant was installed with a blood pressure monitor from a different manufacturer at the end of (b)(6) 2016.Since receiving the new blood pressure monitor.

• Brand Name: IDEAL LIFE BLOOD PRESSURE MONITOR
• Type of Device: IDEAL LIFE BLOOD PRESSURE MONITOR
• Manufacturer (Section D): IDEAL LIFE
• MDR Report Key: 5832763
• MDR Text Key: 50852766
• Report Number: MW5063724
• Device Sequence Number: 1
• Product Code: DRG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BPM 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other