BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6572835 · Received May 17, 2017

    Report

    Report Number
    1000113657-2017-00855
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 24, 2017
    Report Date
    May 17, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. CUSTOMER RETURNED REPLACEMENT METER - UNABLE TO TEST. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. NOTE: AT CALL BACK WAS MADE ON (B)(6) 2017; THE CUSTOMER STATED SHE WAS FEELING BETTER AND DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. THE CUSTOMER STATED SHE DID NOT HAVE ANY MEDICAL INTERVENTION SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 162, 144 AND 183 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 130 MG/DL. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER STATED SHE HAD "PRICKLINESS" IN HER LEFT ARM. CUSTOMER STATED SHE HAD GONE TO URGENT CARE THAT MORNING ((B)(6) 2017) FOR THE "PRICKLINESS" IN HER ARM, AND THAT THE DOCTOR ADVISED HER THAT SHE WAS FINE AFTER HAVING AN EKG DONE. CUSTOMER STATED THAT SHE WAS ADVISED TO CONTINUE TO TAKE ALL HER MEDICATIONS AND NO FURTHER TREATMENT WAS ADMINISTERED. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 277 MG/DL USING TRUEMETRIX METER; CUSTOMER DECLINED TO DO SECOND BLOOD TEST. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/19/2018 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353115 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT2285 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY