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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RELION MANUAL BLOOD PRESSURE MONITOR (MEDICAL QUALITY)

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RELION MANUAL BLOOD PRESSURE MONITOR (MEDICAL QUALITY) Back to Search Results
Model Number 100-021 REL
Device Problems Defective Component (2292); High Readings (2459)
Patient Problem Misdiagnosis (2159)
Event Date 01/29/2017
Event Type  malfunction  
Event Description
Defective bp monitor: i purchased manual blood pressure (bp) monitor at (b)(6), summer 2016. In the past, i had headaches and high bp, side-effects of a neuro med for movement disorder. Recently i had severe headaches on a similar neuro med and used the monitor for the first time (b)(6) 2017. Bp very high 200/120 and because of my prior experience, i did not question the results and took bp meds. Over the nxt 2-3 days, the monitor readings were high, about 180/110 and i continued the blood pressure meds. Saw my doctor (b)(6) 2017 my bp was normal 138/78 on no bp meds. It turns out that my blood pressure has been totally normal, even with the headaches, and this device always reads extremely high and is defective. Are all of them defective? i took unneeded medication for high blood pressure that could have been extremely dangerous. I underwent an unnecessary medical work-up based on my report to the doctor, a report she trusted, as i am myself a medical doctor. How many people are taking unnecessary and potentially dangerous medications based on the faulty readings of this device? i did report the device to (b)(6), probably on (b)(6) 2017, and they are returning my money. I stressed to them that a poorly made device such as this was extremely dangerous and that i wanted the company to take further action. As of today, i have not heard from them. I thank you for looking in to this matter. Sincerely, (b)(6). Took medication for high blood pressure based on the (erroneous) results of the readings on the blood pressure monitor, had 2 doctor appointments, lab tests, ekg (unnecessary). Do you still have the product in case we need to evaluate it: no. Distributed by (b)(6).
 
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Brand NameRELION MANUAL BLOOD PRESSURE MONITOR (MEDICAL QUALITY)
Type of DeviceRELION MANUAL BLOOD PRESSURE MONITOR (MEDICAL QUALITY)
MDR Report Key6356427
MDR Text Key68466509
Report NumberMW5068105
Device Sequence Number1
Product Code DXN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number100-021 REL
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/23/2017 Patient Sequence Number: 1
Treatment
CALCIUM; ESTROGEN; LEVOTHYROXINE; MAGNESIUM; OTC MEDS: IBUPROFEN; PRAMIPEXOLE; PROGESTERONE; RX MEDS: OXYCODONE/ACETAMINOPHEN; TESTOSTERONE; VITAMIN B COMPLEX; VITAMIN B12; VITAMIN D3
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