BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6460167 · Received April 5, 2017

    Report

    Report Number
    1000113657-2017-00618
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    March 13, 2017
    Report Date
    April 5, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007010
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 (KITCHEN). (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 151, 172 AND 174 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 120 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 KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2017 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE NOT SET; MEMORY CONCERNS: CUSTOMER CONCERNED WITH RESULTS DATE (B)(6) 2017 AT 12:56 PM): (B)(6). MEMORY CONCERNS: CUSTOMER CONCERNED WITH RESULTS DATE (B)(6) 2017 AT 12:56 PM. THE CUSTOMER CALLED WITH CONCERNS REGARDING THEIR METER READING HIGH. THEIR NORMAL FASTING GLUCOSE RANGE IS 100MG/DL TO 120MG/DL. THE CUSTOMER DENIES THE NEED FOR MEDICAL ATTENTION AT THE TIME OF CALL. THE CUSTOMER DENIES HAVING ANY SIGNS OR SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA AT THE TIME OF CALL. THE METER'S DATE IS NOT SET UP CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242761 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1821 00021292007010

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY