BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6443389 · Received March 29, 2017

    Report

    Report Number
    1000113657-2017-00584
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    March 7, 2017
    Report Date
    March 29, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00311917173894
    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 OF MALFUNCTION: USER'S TEST STRIP HAD POOR STORAGE (BATHROOM). (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 537 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 - 170 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 IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/23/2018 AND OPEN VIAL DATE IS (B)(6) 2017. CUSTOMER STATED HE HAS HAD A CHANGE IN MEDICATION AND THAT HIS DOCTOR HAS TAKEN HIM OFF TWO DIABETIC MEDICATIONS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY : (B)(6). MEMORY CONCERNS:537 MG/DL. CUSTOMER REFUSED TO GET MEDICAL HELP AND REFUSED TO GO TO THE HOSPITAL . CUSTOMER STATED THAT HE DID NOT HAVE HYPERGLYCEMIA SYMPTOMS. CUSTOMER IS GOING TO GO (B)(6) AND GETTING A NEW METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225746 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1998 00311917173894

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY