BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 5978514 · Received September 26, 2016

    Report

    Report Number
    1000113657-2016-01637
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    September 5, 2016
    Report Date
    October 17, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT DOES NOT RETURN FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIPS HAD A POOR STORAGE(KITCHEN).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER AND RETURNED TEST STRIPS. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:USER'S TEST STRIPS HAD A POOR STORAGE(KITCHEN).

    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 174, 172, 205, AND 151 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 130MG/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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/22/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): REVIEWED METER MEMORY. (B)(6). THE CUSTOMER HAS NOT MADE ANY RECENT CHANGES IN THE DIET, EXERCISE REGIMEN, OR MEDICATION. THE CUSTOMER IS TESTING THREE TIMES A DAY (FASTING). THE CUSTOMER IS STORING THE METER AND TEST STRIPS IN THE KITCHEN; INFORMED THE CUSTOMER OF THE PROPER STORAGE RECOMMENDED BY THE MANUFACTURER.

    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 174, 172, 205, AND 151 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 130MG/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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/22/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). THE CUSTOMER HAS NOT MADE ANY RECENT CHANGES IN THE DIET, EXERCISE REGIMEN, OR MEDICATION. THE CUSTOMER IS TESTING THREE TIMES A DAY (FASTING). THE CUSTOMER IS STORING THE METER AND TEST STRIPS IN THE KITCHEN; INFORMED THE CUSTOMER OF THE PROPER STORAGE RECOMMENDED BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629498 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1889

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY