BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 SERIES WRIST BLOOD PRESSURE MONITOR

    MDR report key: 4131209 · Received September 9, 2014

    Report

    Report Number
    1450057-2014-00004
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 13, 2014
    Manufacturer
    OMRON (DALIAN) CO., LTD (PLANT 1)
    Product Code
    DXN
    PMA / PMN Number
    K042505
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT DUE TO HOME BLOOD PRESSURE MONITOR READING LOW HER HUSBAND HAD A STROKE. CONSUMER REPORTED HUSBAND WAS SITTING ON CHAIR AND ARM WAS RESTING ON CHEST. CONSUMER STATED HER HUSBAND IS TAKING DIFFERENT MEDICATIONS: HYDROCHLOROTHIAZIDE, INVOKANA, SYNTHROID, COZAAR, ZOCOR. CONSUMER CLAIMED BATTERIES WERE REPLACED 2 WEEKS AGO. CONSUMER CLAIMED HER HUSBAND SPENT 4 DAYS IN THE HOSPITAL. PER CONSUMER, THERE WAS A COMPARISON DONE AT THE HOSPITAL WITH HOME UNIT AND HOME UNIT WAS READING LOW. THEY DID NOT KNOW WHAT NORMAL BLOOD PRESSURE (BP) READINGS IS. CONSUMER REPORTED HAS THREE SHEETS OF READINGS HER HUSBAND TOOK WITH HOME BP MONITOR. CONSUMER HAS PURCHASED AUTOMATIC ARM BP MONITOR (BP710) SINCE CANNOT BE WITHOUT THE BP MONITOR. CONSUMER REFUSED TO SEND THE UNIT BACK TO FURTHER INVESTIGATION SINCE THIS IS HER PROOF THIS HAPPENED TO HER HUSBAND. CUSTOMER SERVICE REP EXPLAINED THE PROPER PROCEDURE TO FOLLOW WHEN TAKING BLOOD PRESSURE MEASUREMENT. DURING FOLLOW UP WITH QUALITY REP, END USER'S WIFE CLAIMED CUSTOMER CLAIMING LOW READINGS FOR 2 MONTHS WHILE USING THE UNIT. APPROXIMATE READINGS AROUND 148/XX AND AT THE HOSPITAL HIS READINGS WERE 207/60. PT WAS ADVISED BY DOCTOR TO PURCHASE UNIT TO MONITOR BP FROM (B)(6) 2014. CUSTOMER STARTED ACTING WEIRD AND INCOHERENT WHICH PROMPTED TAKING HIM TO THE HOSPITAL. WHEN CUSTOMER GOT TO HOSPITAL THE DIAGNOSIS WAS A BROKEN BLOOD VESSEL. CUSTOMER CLAIMING 20-50 POINT DIFFERENCE IN READINGS BETWEEN OMRON UNIT AND HOSPITAL BP UNIT READINGS. AT THE HOSPITAL, HIS BLOOD PRESSURE WAS 160 AND DOCTOR HAD TROUBLE BRINGING IT DOWN. AFTER CHANGING MEDICATION IT WAS DOWN TO AROUND 130 AT THE TIME HE WAS RELEASED FROM THE HOSPITAL. CUSTOMER WRIST SIZE IS 7 3/4. CUSTOMER BOUGHT NEW UNIT (BP710) AND CURRENTLY GETTING READINGS AROUND 144/XX. QUALITY ANALYSIS REMINDED CONSUMER THAT THE HOME MONITOR IS NOT A DIAGNOSTIC DEVICE AND TAKING MEDICATION AS PRESCRIBED BY THE DOCTOR. CUSTOMER CLAIMED MEDICATION WAS NOT ADJUSTED BASED ON HOME UNIT BP READINGS. CUSTOMER AGREED TO SEND THE UNIT BACK FOR INSPECTION. A POSTAGE PAID LABEL HAS BEEN SENT FOR RETRIEVAL OF THE HOME UNIT FOR INSPECTION. QUALITY REP CALLED CUSTOMER AGAIN ON (B)(6) 2014 TO GET AN UPDATE ON SHIPPING UNIT BACK FOR INVESTIGATION. UNIT HAS NOT BEEN RECEIVED BACK AS OF (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556352 3 SERIES WRIST BLOOD PRESSURE MONITOR WRIST BLOOD PRESSURE MONITOR DXN OMRON (DALIAN) CO., LTD (PLANT 1) BP629 20130702015LF

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R