MAUDE Adverse Event Report: OMRON HEALTHCARE CO., LTD. OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR

Model Number BP7100

Device Problem High Readings (2459)

Patient Problems Fainting (1847); Bone Fracture(s) (1870); Laceration(s) (1946); Electrolyte Imbalance (2196)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

The instruction manual for the home unit (model bp7100) has following warning listed."do not adjust medication based on readings from this blood pressure monitor.Take medication as prescribed by your physician.Only a physician is qualified to diagnose and treat high blood pressure." "never diagnose or treat yourself based on your readings.Always consult with your physician." a postage paid label was sent to retrieve the unit for further investigation and verbal request for unit return was made.A root cause has not been determined.It has not been confirmed if the device caused or contributed to the reported incident.However, due to the customer reporting hospitalization and receiving medical treatment, this medwatch is being filed.

Event Description

Consumer reported that the unit was reading high and was given a medication based on those readings.After the medication change, she fainted twice, was injured, and was in the hospital for 36 hours.She is the only user, using it three times a day and has had unit since (b)(6) 2020.Per consumer, the unit has been reading high from the first use.The cuff size is correct and the cuff was secured.The average blood pressure when using this machine was in the ~ high range of 130's over high 80's.At the doctor's office, her reading was 114/76.Consumer stated at the doctor's office, omron unit inflated to 150 to 170 and gave reading of 140/90.At the hospital, her reading was very low.After a sodium drip, it came up to more normal reading.Consume stated her home unit read high so she called doctor and doctor changed her medication to diuretic.The customer fainted twice and her pressure at that time was 72/56.At the hospital, her medication was changed at the hospital.The customer was in the hospital for 36 hours.She had a broken thumb and facial lacerations.Blood work and echocardiogram.X-rays of hand and chest.Cat scan for brain bleed.During follow-up call on march 9, consumer stated the omron unit was reading high so she called her doctor and her doctor prescribed diuretic to add along with her current medication.The diuretic depleted the sodium in her system causing her to faint.Consumer stated she has a broken thumb and a laceration over the left eyebrow.Consumer was told that the laceration was deep but it was a clean cut so they were able to glue it shut.Consumer reported it did bleed a lot but that is common for head injuries.They gave her a sodium drip to get her levels back up.The thumb has a fracture through it and is in a splint.They did blood work, echocardiogram.X-rays of hand and chest, and cat scan for brain bleed.Consumer indicated a side from x-ray showing the fracture and the blood work showing the low sodium, all of the other testing came back okay and once her sodium came back up they were able to discharge her.Consumer would like get the refund for the unit.Consumer was advised not to adjust medication based on the measurement results from the blood pressure monitor and only physician is qualified to diagnose and treat high blood pressure.A refund request was submitted and a postage paid label was sent for retrieval of the home unit for further investigation.

Manufacturer Narrative

Updated information: section 10: consumer returned the unit back to importer for evaluation.The importer evaluated the returned unit and it passed evaluation.Then, the returned unit was sent to device manufacturer for further testing on may 2, 2020.Here is the summary of the manufacturer device investigation: the unit was tested and it passed all specification tests.The manufacturer reviewed the qa test data and complaint history for similar issues.No issue/problem was noted during data reviewed by the manufacturer.No issue or increasing trend was noted.The instruction manual has the warning stating not adjusting medication based on bp monitor reading and only physician is qualified to diagnose and treat high blood pressure.The risk analysis document was reviewed and it was determined that no update to risk management documents is required.Since there was no issue found with returned device; further investigation and correction is not necessary.

• Brand Name: OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): OMRON HEALTHCARE CO., LTD.; 53 kunotsubo terado-cho; muko-city, kyoto 61700 02; JA 6170002
• MDR Report Key: 9827556
• MDR Text Key: 193011962
• Report Number: 8030245-2020-00001
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00073796710026
• UDI-Public: (01)00073796710026
• Combination Product (y/n): N
• PMA/PMN Number: K133379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BP7100
• Device Catalogue Number: BP7100
• Device Lot Number: 201905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 59