BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 7004367 · Received November 6, 2017

    Report

    Report Number
    1000113657-2017-01910
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 19, 2017
    Report Date
    November 6, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007447
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. TEST STRIP UDI# (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 164, 181, 170, 177 AND 208 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 120 MG/DL. CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. HUSBAND STATED CUSTOMER HAD A ROUTINE DOCTOR'S VISIT (B)(6) 2017 AND RESULTS WERE WITHIN RANGE. CUSTOMER THEN TESTED WITH TRUEMETRIX AIR METER AND OBTAINED RESULT OF 164 MG/DL FASTING. HUSBAND STATED CUSTOMER IS OBTAINING RESULTS THAT ARE OUT OF RANGE DAILY. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; CUSTOMER HAD EATEN LESS THAN TWO HOURS PRIOR. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATES THE METER IS READING HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783576 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MU2463 00021292007447

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR