BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6591393 · Received May 25, 2017

    Report

    Report Number
    1000113657-2017-00904
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Date of Event
    May 2, 2017
    Report Date
    May 25, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00087701427398
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED THAT HE TOOK HIS METER TO THE DOCTOR (CUSTOMER HAD A PREVIOUS APPOINTMENT) AND THEY RAN A BLOOD TEST AND COMPARED IT WITH THEIR METER AND THE TRUE METRIX METER WAS GIVING HIGHER RESULTS (COMPARISON RESULTS NOT PROVIDED). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 151 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 86 - 100 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018 AND CUSTOMER STATED STRIPS HAVE BEEN OPEN FOR ABOUT THREE - FOUR MONTHS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET):128MG/DL (B)(6) 2016 06:35 PM FASTING: YES; 151MG/DL (B)(6) 2016 06:09 PM FASTING: YES; 136MG/DL (B)(6) 2016 06:04 PM FASTING: YES; 128MG/DL (B)(6) 2016 06:21 PM FASTING: YES;129MG/DL (B)(6) 2016 01:59 PM FASTING: YES. MEMORY CONCERNS: CUSTOMER IS CONCERN WITH ALL THESE RESULTS. CUSTOMER CALLING STATES THAT METER IS NOT GIVING ACCURATE RESULTS. THE RESULTS ARE TOO HIGH. CUSTOMER STATES THAT THE METER IS GIVING ABOUT 20-60MG/DL HIGHER THAN THE TRUE RESULTS METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372496 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT2214 00087701427398

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR