BEUDAMED
    FDA Adverse Event Other Summary report: N

    IBLOOD PRESSURE - REMOTE PATIENT MONITORING DEVICE

    MDR report key: 16015994 · Received December 19, 2022

    Report

    Report Number
    MW5113859
    Event Type
    Other
    Date Received
    December 19, 2022
    Report Date
    April 15, 2024
    Manufacturer
    SMART METER LLC
    Product Code
    DXN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DESCRIPTION: THIS DEVICE 863850041083937 HAS A FIRMWARE BUG REFERRED TO BY THE MANUFACTURER AS "NTP"(NETWORK TIME PROTOCOL) WHICH CAUSES THE SMBP802-GS-001 DEVICE TO STOP WORKING WHEN BATTERIES ARE REMOVED. THIS DEVICE IS SPECIFICALLY USED FOR TELEHEALTH MONITORING AND REMOTE PHYSIOLOGICAL MONITORING BY HEALTH CARE PROFESSIONALS FOR REMOTE MANAGEMENT OF PATIENTS REQUIRING BLOOD PRESSURE MANAGEMENT AND CONTROL. I AM CONCERNED THE COMPANY IS NOT FOLLOWING FDA PROTOCOL REPORTING DEVICE FAILURES AND NOT COMMUNICATING TO THEIR CUSTOMERS AND ADVISING OF THE SAME. IN MY OPINION, I BELIEVE SMART METER LLC IS DEMONSTRATING A FLAGRANT DISREGARD FOR PATIENT SAFETY. I HAVE ALWAYS REPORTED ALL RELATED ISSUES PROMPTLY AND DIRECTLY TO SMART METER LLC UPON RECOGNITION AS LISTED BELOW AND HAVE RELIED ON SMART METER LLC TO BE IN COMPLIANCE. SMART METER LLC HAS ADDITIONAL DOCUMENTED ISSUES INCLUDING BUT NOT LIMITED TO; BLOOD PRESSURE CUFF ERROR -BP CUFFS FAIL TO INFLATE GENERATES ERROR CODE E1. PRODUCT LABELS ON THE DEVICE AND BOX BECOME ILLEGIBLE. IMEI NUMBERS DUE TO PRINTER INK ARE DRIPPED AND ARE EXTREMELY DIFFICULT TO DISTINGUISH A "5" FROM A "6" WITH A FONT SIZE THAT IS BARELY VISIBLE TO THE NAKED EYE. THIS INCREASES THE PROBABILITY OF END-USER ERROR WHEN ASSIGNING DEVICES TO PATIENTS. IN ADDITION, THE DEVICE LABEL INK EVAPORATES OVER TIME AND BECOMES MISSING WITH THE END RESULT LEAVING THE DEVICE WITH A BLANK LABEL. THIS MAKES TRACKING AND QUARANTINING DEVICES EXTREMELY DIFFICULT. WITHOUT A LABEL, THERE IS NO OTHER DISTINGUISHABLE METHOD TO DETERMINE THE IMEI. PRIMARY KEY VIOLATION- THE SMBP802-GS-001 GENERATED DUPLICATE VALUES AS HIGH AS "10" OR MORE AT A TIME THAT ARE NANO SECONDS APART. TO THE BEST OF MY KNOWLEDGE, SMART METER LLC HAS NOT FORMALLY SENT A NOTIFICATION TO ALL OF ITS CUSTOMERS ADVISING OF THIS ISSUE AND THE REQUIRED STEPS TO REPORT IT. I HAVE NEVER RECEIVED A FORMAL NOTICE. SMBP802-GS-001 THE DISPLAY THAT THE PATIENT WILL SEE IS A "DATE AND TIME" DISCREPANCY WITH AS MUCH AS 24 HOURS OFFSET. I AM PROVIDING THIS INFORMATION AS MY DUTY TO ENSURE PATIENT SAFETY. IF THE MANUFACTURER HAS REPORTED THESE ISSUES AND IS IN COMPLIANCE WITH FDA MEDICAL DEVICE REPORTING THEN I WILL BE SATISFIED THAT THE FDA IS AWARE. IN ALL OF THE YEARS, I HAVE NEVER HAD TO REPORT SAFETY CONCERNS OR ISSUES DUE TO A MEDICAL DEVICE. TO THE BEST OF MY KNOWLEDGE, I AM UNAWARE OF ANY PATIENT INJURIES RELATED TO SMART METER LLC SMBP802-GS-001.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED TO UPDATE EVENT ON 4/15/2024 FOR REPORT MW5113859. WE HAVE EXPERIENCED AN UNPRECEDENTED NUMBER OF DEVICE FAILURES SINCE THE FALL OF 2021.1 HAVE BEEN IN THE DURABLE MEDICAL EQUIPMENT INDUSTRY FOR OVER 25 YEARS AND HAVE NEVER EXPERIENCED THIS KIND OF MISCONDUCT. WE HAVE WORKED CLOSELY WITH THE MANUFACTURER AND UNFORTUNATELY, WERE FORCED TO REPORT MDR. THE DEFECTS ARE ADMITTED BY SMART METER AS A FIRMWARE ANOMALY FROM A SINGLE LOT NUMBER OF IBLOODPRESSURE MODEL 5M5000 DEVICES MANUFACTURED BEFORE MAY 2021. DESPITE OUR BEST EFFORTS AND PATIENT ADVOCACY, SMART METER REFUSES TO PROVIDE A FORMAL EXPLANATION OF ALL OF THE DEFECTS AND WILL NOT ANSWER A SIMPLE QUESTION AS TO WHETHER A SERIES OF IMEI (INTERNATIONAL MOBILE EQUIPMENT IDENTITY) ARE DEFECTIVE. THE IME NUMBERS ARE SEQUENTIAL BASED ON TIME OF MANUFACTURER DATE. I BELIEVE THIS AN ATTEMPT BY SMART METER TO PLACE PROFIT OVER PUBLIC SAFETY AS THESE DEVICES BY FDA STANDARDS MAY MEET THE REQUIREMENTS OF A RECALL. SINCE THEN, WE HAVE OBSERVED A PATTERN OF AN "UNSPECIFIED LOT NUMBER" (KNOWN ONLY TO THE MANUFACTURE) DESCRIBED BY SMART METER AS "SMALL" AND "ISOLATED" WITH FATAL FLAWS RELATED TO BUT NOT LIMITED TO THE IMEI SEQUENCES LISTED ABOVE. THE DEVICES IN QUESTION ACCORDING TO SMART METER WERE MANUFACTURED BEFORE MAY 2021 AND ARE PRONE TO A FIRMWARE DEFECT. THE DEVICE WILL DEFAULT TO 12:00AM (SEE FIGURE 1). IN ADDITION, DATA ERRORS APPEAR COMMON INCLUDING ANOTHER FIRMWARE DEFECT ADMITTED BY SMART METER 6/24/22 WHICH CAUSES THE DATA AND TIME TO BE INCORRECT WHERE THE DATA RESIDES AND ADDITIONAL ANOMALIES HAVE BEEN OBSERVED. WE WERE TOLD TO DISCARD 337 DEFECTIVE DEVICES IN JUNE 2022. THE ISSUES ARE LISTED BELOW AND INCLUDE BUT ARE NOT LIMITED TO; MULTIPLE BLOOD PRESSURE AND HEART RATE DISCREET READINGS SECONDS A PART BELIEVED TO BE PHANTOM IN NATURE. THIS DEFECT COULD HARM A PATIENT BEING TREATED FOR HEART DISEASE BY UNDERTREATING OR OVER TREATING THE CONDITION. DUPLICATE VALUES (PRIMARY KEY VIOLATION) SMART METER INSTALLED A SOFTWARE PATCH 8/15/2022 ON THEIR SERVER. PROVIDERS WERE NEVER GIVEN NOTICE OF THE PATCH AND A FULL EXPLANATION OF THE PROBLEM AND THE IMPACT IT COULD HAVE HAD ON THEIR PATIENT POPULATION. THIS ISSUE CAN FALSELY SKEW THE READING AVERAGE CAUSING POTENTIAL PATIENT HARM BY UNDER OR OVER TREATING THE HEART CONDITION. NET WORK TIME PROTOCOL (NTP) WHERE THE FIRMWARE DOES NOT UPDATE WHEN THE DEVICE CONNECTS TO A CELL TOWER WHICH SETS THE READING TIME TO 5HRS UTC. THE DEVICE STOPS WORKING AND/OR IT LOSES THE ABILITY TO SEND THE DATA TO THE SERVER. THIS GIVES PATIENTS A FALSE SENSE OF SECURITY AND DELAYS IN PATIENT CARE. NONE OF THE ABOVE ISSUES ARE LISTED IN THE OWNER'S MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858710 IBLOOD PRESSURE - REMOTE PATIENT MONITORING DEVICE SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN SMART METER LLC SMBP802-GS-001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown