BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6551907 · Received May 8, 2017

    Report

    Report Number
    1000113657-2017-00801
    Event Type
    Malfunction
    Date Received
    May 8, 2017
    Date of Event
    April 13, 2017
    Report Date
    May 8, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007911
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 90, 100 AND 246 MG/DL (FASTING, BACK TO BACK). THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 130 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 BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2017. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/18/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: 90, 100, 246. CUSTOMER CALLED CONCERNING ERRATIC RESULTS. SAYS THAT SHE TESTED 3 TIMES WITHIN A 20 MINUTE PERIOD AND GLUCOSE LEVEL JUMPED FROM 246MG/DL TO 90MG/DL. CUSTOMER PERFORMED CONTROL TEST AND METER IS READING ACCURATELY BUT CUSTOMER IS UNSATISFIED WITH METER AND WANTS REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333462 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT2102 00021292007911

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY