BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6048524 · Received October 21, 2016

    Report

    Report Number
    1000113657-2016-01763
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 21, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 202, 346, 173 AND 174 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 128-160 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 FASTING AND PRODUCED TEST RESULTS OF 202 AND 346 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 6/30/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): 202MG/DL, (B)(6) 2016 07:26 AM, FASTING: YES; 173MG/DL, (B)(6) 2016 07:42 AM, FASTING: YES; 174MG/DL, (B)(6) 2016 07:29 AM, FASTING: YES; 155MG/DL, (B)(6) 2016 06:34 AM, FASTING: YES; 146MG/DL, (B)(6) 2016 07:47 AM, FASTING: YES. MEMORY CONCERNS: 202. THE CUSTOMER CALLED AND STATES THAT HE JUST GOT A HIGHER READING THAN HIS NORMAL RANGE OF 128-160MG/DL ON HIS METER. THE CUSTOMER STATES HE IS FEELING GOOD AND DENIES ANY DIABETIC SYMPTOMS. THE CUSTOMER ALSO STATES THE STRIPS ARE ABSORBING THE BLOOD SAMPLES SLOWER THAN USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698687 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1766

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY