BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7342838 · Received March 15, 2018

    Report

    Report Number
    1000113657-2018-00310
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    March 1, 2018
    Report Date
    March 15, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00050428275283
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-18- USER HAS HIGH GLUCOSE VALUE. TEST STRIP (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER ON 3/9/2018 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 190-230 MG/DL. THE CUSTOMER FEELS WELL AND DID/ DID NOT REPORT SYMPTOMS AT INITIAL TIME OF THE CALL. MEDICAL ATTENTION IS REPORTED. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/15/2018 AND OPEN VIAL DATE IS (B)(6) 2017 (EXPIRED). THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER CALLED BACK AND CLAIMED ON (B)(6) 2018 CUSTOMER CHANGED THE BATTERY ON THE METER BECAUSE HE HAD A LOW BATTERY AND THEN THE METER READ 565 MG/DL FASTING. CUSTOMERS METER ALSO READ HI. CUSTOMER WENT TO THE ER 15 MINUTES LATER AND THE ER READ HIS BLOOD SUGAR AT 364 MG/DL FASTING. CUSTOMER FELT A LITTLE BLURRY VISION. CUSTOMER HAD AN EKG, AN XRAY, AND WAS ALSO PLACED ON 2 IV BAGS. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA. CUSTOMERS TEST STRIPS WERE EXPIRED. EDUCATED CUSTOMER ON OPEN VIAL EXPIRATION DATE. CUSTOMER DID NOT HAVE ANY OTHER TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184674 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2470 00050428275283

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR