BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6604587 · Received June 1, 2017

    Report

    Report Number
    1000113657-2017-00937
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Date of Event
    May 9, 2017
    Report Date
    June 1, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00010939719447
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: MLC-20 USER'S TEST STRIP HAD POOR STORAGE.(KITCHEN). TEST STRIP UDI# (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 120MG/DL. THE CUSTOMER DID REPORT SYMPTOM OF FEELING LOW. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/20/2017 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 51MG/DL (B)(6) 2017 04:33 PM FASTING: YES, THE 49MG/DL (B)(6) 2017 04:31 PM FASTING: YES, THE 57MG/DL (B)(6) 2017 04:28 PM FASTING: YES. CUSTOMER IS STATED THAT SHE FELT LOW; CUSTOMER BLOOD GLUCOSE WAS 51MG/DL. CUSTOMER DENIED THE NEED FOR AN AMBULANCE BUT CUSTOMER REPRESENTATIVE CONTINUED TO STAY ON THE LINE WITH THE CUSTOMER AND HAVE HER EAT. SHE CONTINUALLY REFUSED AN AMBULANCE OR MEDICAL CARE. CUSTOMER STATED THAT SHE DID NOT FEEL SHE HAD SIGNS OR SYMPTOMS OF HYPOGLYCEMIA. CUSTOMER IS STATED THAT HER METER WAS READING LOW BUT SHE DENIED MEDICAL ATTENTION. SHE STATED THAT SHE DROPPED HER STRIPS SEVERAL TIMES AND QUESTIONING WHETHER THE STRIPS ARE ANY GOOD. CUSTOMER DOES NOT HAVE HYPOGLYCEMIC SYMTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386496 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1743 00010939719447

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR