MAUDE Adverse Event Report: UNKNOWN GARMIN INDEX BPM; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number	BP707
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Using the garmin index bpm monitor that i purchased a few days ago, i have been consistently getting blood pressure readings that are 20+ points off (higher) on the systolic and 12-15 points off on the diastolic, when compared to a manual reading and other devices (omron).The product complaint department at garmin is less than satisfactory for medical device product complaints.If you want further information on their standard operating procedures, please contact me at (b)(6).I am sending the unit back for a full refund, so i will not have the product in my possession past today.Had i not verified and calibrated the garmin readings as compared to other devices and a manual, i may have been asked to adjust my bp meds accordingly, which may have resulted in hypotension with higher doses, or more potent therapy.Fda safety report id #(b)(4).

• Brand Name: GARMIN INDEX BPM
• Common Device Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15680773
• Report Number: MW5112910
• Device Sequence Number: 7368026
• Product Code: DXN
• UDI-Device Identifier: 04719873310074
• UDI-Public: (01)04719873310074
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BP707
• Device Catalogue Number: 010-02464-00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OMRON BLOOD PRESSURE MONITOR; PROPRANOLOL 120 MG PER DAY, OLMESARTIN 20 MG PER DAY, ROSUVASTATIN 10 MG POER DAY, ASA 81 MG PER DAY.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White