BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 5936586 · Received September 8, 2016

    Report

    Report Number
    1000113657-2016-01472
    Event Type
    Malfunction
    Date Received
    September 8, 2016
    Date of Event
    August 16, 2016
    Report Date
    September 8, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    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 133, 84 AND 125 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 50 - 125 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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 281 MG/DL AND 261 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/23/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE CUSTOMER STATED THAT HE HAS NOT HAS ANY CHANGES TO HIS LIFESTYLE. THE CUSTOMER STATED HE ISS CURRENTLY ON METFORMIN, TWO 500 MG TABLETS AT BEDTIME. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: CUSTOMER IS CONCERNED WITH RESULTS: 148 MG/DL, 133 MG/DL THE CUSTOMER VERIFIED THAT HE HAS NOT HAS ANY CHANGES TO HIS LIFESTYLE. I RAN A CONTROL TEST WITH THE CUSTOMER WITH A RESULT OF 43 MG/DL, WHICH WAS WITHIN RANGE. CONTROL LOT # 6BC1A14; OPEN VIAL DATING: (B)(6) 2016. LEVEL: 1, RANGE: 23-53 MG/DL, RESULT: 43 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587468 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1688

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY