BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 7306004 · Received March 1, 2018

    Report

    Report Number
    1000113657-2018-00246
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    February 5, 2018
    Report Date
    March 1, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007447
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-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). NOTE: MANUFACTURER CONTACTED CUSTOMER ON 2/20/2018 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION SINCE THE LAST CALL.

    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 220, 324, 214 AND 206 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 116 - 138 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. CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/15/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :214MG/DL DATE:(B)(6) 2018 TIME:10:51PM FASTING, RESULT 2 :220MG/DL DATE:(B)(6) 2018 TIME:11:12PM FASTING, RESULT 3 :145MG/DL DATE:(B)(6) 2018 TIME:06:07PM FASTING, RESULT 4 :193MG/DL DATE:(B)(6) 2018 TIME:10:09PM FASTING, RESULT 5 :206MG/DL DATE:(B)(6) 2018 TIME:07:04PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149901 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MU2389 00021292007447

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR