BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 9089872 · Received September 19, 2019

    Report

    Report Number
    1000113657-2019-00931
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    August 26, 2019
    Report Date
    May 6, 2020
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) SECTIONS WITH ADDITIONAL INFORMATION AS OF 06-MAY-2020: H10: METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED AND PASSED. INTERNAL REPORT: (B)(4). REPORT NUMBER: MW5088721. NOTIFICATION RECEIVED THI: 26-AUG-2019. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-55: USER HAD AN INACCURATE REFERENCE: COMPETITOR'S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR'S BGM SYSTEM TEST STRIPS UDI: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO OBTAIN MORE INFORMATION ABOUT THE COMPLAINT - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    I PURCHASED A SUNMARK TRUE METRIX METER AND STRIPS IN (B)(6) 2019 FROM (B)(6) PHARMACY. MY BLOOD SUGARS HAVE BEEN RUNNING HIGH EVERY TIME I STARTED USING THEIR FAULTY EQUIPMENT AND STRIPS RUNNING AS HIGH AS 237 WITH AN AVERAGE OF 159 DESPITE MY PREVIOUS A1C BEING 5.3. TODAY MY FASTING BLOOD SUGAR WAS 176 NPO SO I DECIDED TO GO SEE MY PHYSICIAN WHO HAS BEEN MAKING ONE RX CHANGE AFTER ANOTHER TO GET MY BLOOD SUGAR DOWN. WHILE STILL NPO I CHECK MY BLOOD SUGAR AT THE PHYSICIAN'S OFFICE WITH A RESULT OF 172. THE NURSE THEN CHECKED WITH THEIR ACCURATE POC SYSTEM AND IT WAS 109, A 63-POINT ERROR REPRESENTING A 37% DEVIATION. THANKFULLY I HAVE NOT BEEN DOSING REGULAR INSULIN WHEN YOUR FAULTY EQUIPMENT AND TEST STRIPS REPORTED MY BLOOD SUGAR HIGH OR I WOULD HAVE BEEN HYPOGLYCEMIC SEVERAL TIMES. EVERY DIABETIC PT IN AMERICA WHO TESTS THEIR BLOOD SUGAR NEEDS TO KNOW ABOUT THEIR FAULTY EQUIPMENT AND TEST STRIPS. FOR A DIABETIC, THIS TYPE OF INACCURACY COULD MEAN A DIABETIC COMA AND DEATH. THIS EQUIPMENT NEEDS TO BE REMOVED FROM THE MARKET, JUNK. THANKS.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT: (B)(4). REPORT NUMBER: MW5088721. NOTIFICATION RECEIVED THI: 26-AUG-2019. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-55: USER HAD AN INACCURATE REFERENCE: COMPETITOR'S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR'S BGM SYSTEM TEST STRIPS UDI: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO OBTAIN MORE INFORMATION ABOUT THE COMPLAINT - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    I PURCHASED A SUNMARK TRUE METRIX METER AND STRIPS IN (B)(6) 2019 FROM (B)(6) PHARMACY. MY BLOOD SUGARS HAVE BEEN RUNNING HIGH EVERY TIME I STARTED USING THEIR FAULTY EQUIPMENT AND STRIPS RUNNING AS HIGH AS 237 WITH AN AVERAGE OF 159 DESPITE MY PREVIOUS A1C BEING 5.3. TODAY MY FASTING BLOOD SUGAR WAS 176 NPO SO I DECIDED TO GO SEE MY PHYSICIAN WHO HAS BEEN MAKING ONE RX CHANGE AFTER ANOTHER TO GET MY BLOOD SUGAR DOWN. WHILE STILL NPO I CHECK MY BLOOD SUGAR AT THE PHYSICIAN'S OFFICE WITH A RESULT OF 172. THE NURSE THEN CHECKED WITH THEIR ACCURATE POC SYSTEM AND IT WAS 109, A 63-POINT ERROR REPRESENTING A 37% DEVIATION. THANKFULLY I HAVE NOT BEEN DOSING REGULAR INSULIN WHEN YOUR FAULTY EQUIPMENT AND TEST STRIPS REPORTED MY BLOOD SUGAR HIGH OR I WOULD HAVE BEEN HYPOGLYCEMIC SEVERAL TIMES. EVERY DIABETIC PT IN AMERICA WHO TESTS THEIR BLOOD SUGAR NEEDS TO KNOW ABOUT THEIR FAULTY EQUIPMENT AND TEST STRIPS. FOR A DIABETIC, THIS TYPE OF INACCURACY COULD MEAN A DIABETIC COMA AND DEATH. THIS EQUIPMENT NEEDS TO BE REMOVED FROM THE MARKET, JUNK. THANKS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883359 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MW3260S

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY| SECOND THERAPY