BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMRON WRIST BLOOD PRESSURE MONITOR

    MDR report key: 6037595 · Received October 18, 2016

    Report

    Report Number
    3001373226-2016-00002
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    August 8, 2016
    Report Date
    December 2, 2016
    Manufacturer
    OMRON (DALIAN) CO., LTD. (PLANT 1)
    Product Code
    DXN
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013028. (B)(4). CONSUMER DID NOT PROVIDE MODEL NUMBER AND THEREFORE, ACTUAL PLACE OF MANUFACTURE COULD NOT BE DETERMINED. THE U.S IMPORTER IS REQUESTING MANUFACTURE OF THE DEVICE TO FURTHER INVESTIGATE THIS INCIDENT. A ROOT CAUSE HAS NOT BEEN DETERMINED. IT HAS NOT BEEN CONFIRMED THAT THE BLOOD PRESSURE MONITOR PROVIDED AN INACCURATE RESULT OR IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, DUE TO THE NEED FOR MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013028. (B)(4). ADDITIONAL INFORMATION ADDED TO DEVICE EVALUATED BY MFR?, EVALUATION CODES AND ADDITIONAL MFR NARRATIVE. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CONSUMER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER WERE UNABLE TO REACH CONSUMER. IN ADDITION, A POSTAGE PAID LABEL WAS SENT TO RETRIEVE THE UNIT BACK FOR INSPECTION. THE DEVICE HAS NOT BEEN RETURNED AS OF 12/1/2016. THE MODEL NUMBER AND LOT NUMBER WERE NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. WITHOUT RETURN OF THE PRODUCT, THE DEVICE MANUFACTURER IS UNABLE TO PERFORM A COMPLETE INVESTIGATION INTO THE ROOT CAUSE OF THE REPORTED EVENT. AT THIS TIME, THE MANUFACTURER CANNOT CONFIRM THE REPORTED ISSUE. THE DEVICE MANUFACTURER REVIEWED THE RISK ANALYSIS FOR MAJOR WRIST BLOOD PRESSURE MONITORS (BPM). EVENTS/PROBLEMS RELATING TO INACCURATE READINGS HAVE BEEN ANALYZED. RISK MITIGATIONS, WARNINGS AND CAUTIONS ARE DOCUMENTED IN THE RISK FILES AS APPLICABLE. REVIEW OF COMPLAINT HISTORY SHOWED THERE WAS A REPORTABLE EVENT FOR WRIST BPM. ADDITIONALLY, THE UNIT WAS NOT RETURNED FOR THE PREVIOUS REPORTABLE EVENT THEREFORE, A PROBLEM WITH DEVICE COULD NOT BE CONFIRMED AT THAT TIME. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; CONSEQUENTLY, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A LETTER WAS RECEIVED ON (B)(6) 2016 ADDRESSED TO OMRON BOARD OF DIRECTORS, TRUSTEES, AND ASSOCIATES OF OMRON. IN THE LETTER SENT BY THE CONSUMER THE FOLLOWING COMMENTS WERE STATED. YESTERDAY, HER HUSBAND RETURNED HOME FROM A HOSPITAL STAY FROM A NEAR STROKE EXPERIENCE. HE HAD BEEN FEELING ILL, BUT MOSTLY JUST FEELING NAUSEATED. NAUSEA IS NOT ENOUGH TO GO TO THE DOCTOR SO THEY LOOKED FOR OTHER VITAL SIGNS AND SYMPTOMS. THEY CHECKED HIS BLOOD PRESSURE MULTIPLE TIMES ON THE WRIST DEVICE WITH COMPLETELY NORMAL READINGS. SHE INSISTED THAT HE GO TO THE HOSPITAL, IN SPITE OF THE NORMAL BP (BLOOD PRESSURE) READINGS. THEY ARRIVED AT THE HOSPITAL AND HIS BLOOD PRESSURE WAS 260/196- WELL IN TO STROKE RANGE. THE HOSPITAL DOCTOR INFORMED THEM THAT IN NO WAY, SHAPE, OR FORM, WAS HE ANYWHERE CLOSE TO BEING NORMAL. THEY ALSO INFORMED THAT HIS READINGS HAVE NOT BEEN NORMAL FOR SOME TIMES. THE HOSPITAL ALSO SAID THAT WHATEVER DEVICE CONSUMER USED TO OBTAIN THESE READINGS WAS INACCURATE AND WAS ALMOST THE CAUSE OF HER HUSBAND'S DEATH. THEY ALSO SAID THAT NOT ONLY DID THAT DEVICE NOT GIVE ACCURATE READINGS, BUT THE LACK OF THOSE READINGS ALMOST KILLED HER HUSBAND! CONSUMER WROTE SHE UNDERSTANDS THAT OMRON PRODUCT DOES NOT REPLACE THE ROLE OF FAMILY DOCTOR, NOR DID THEY EXPECT IT TO. THEY USED IT TO SUPPLEMENT DOCTOR'S VISITS AND TO MONITOR HOME HEALTH TO STAY AHEAD OF ANY ABNORMALITIES. FURTHERMORE, CONSUMER WROTE THE WRIST BP MONITOR WAS MORE THAN 20-40 POINTS OFF FROM AN ACCURATE READING, AND IT WAS NOT GIVING READINGS ANYWHERE CLOSE TO INDICATING A PROBLEM. NOT ONLY DID THE DEVICE FAIL IN ITS ABILITY TO GIVE AN ACCURATE READING, BUT IT ISN'T GIVING A READING AT ALL. THEY WERE TOLD NOT TO WORRY ABOUT THE NAUSEA BECAUSE WITHOUT HIGH BP READINGS HE WOULD BE FINE. THEY MONITORED HIS BP FOUR-FIVE TIMES A DAY ON OMRON'S DEVICE. THE BP MACHINE SHOWED PERFECT BP OVER TWO WEEKS. CONSUMER WROTE THAT OMRON ALMOST STOLE LIFE OF HER HUSBAND. SHE HAS PROBLEM WITH OMRON SELLING PRODUCTS AND CLAIMED SHE WILL BE PURSUING LEGAL ACTION AND GOING TO THE NATIONAL PRESS TO ENSURE OMRON IS NO LONGER ALLOWED TO ENDANGER THE LIVES OF FAMILY. SHE NOT ONLY WOULD WANT HER MONEY BACK FOR THE MACHINE BUT WANTS APPROPRIATE DAMAGE COMPENSATION INCLUDING MEDICAL BILLS AND PAIN AND SUFFERING. QUALITY ANALYST (QA) MADE MULTIPLE ATTEMPTS (ON (B)(6) 2016) TO REACH CONSUMER TO OBTAIN ADDITIONAL INFORMATION. NO ANSWER. QA LEFT MESSAGE WITH CONSUMER REQUESTING A CALL BACK. IN ADDITION, CONSUMER WAS SENT A WRITTEN REQUEST REQUESTING CONSUMER TO CALL TO PROVIDE ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689950 OMRON WRIST BLOOD PRESSURE MONITOR OMRON AUTOMATIC BLOOD PRESSURE MONITOR DXN OMRON (DALIAN) CO., LTD. (PLANT 1) ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R