BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6713630 · Received July 14, 2017

    Report

    Report Number
    1000113657-2017-01424
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    June 2, 2017
    Report Date
    July 14, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00011822590051
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. RETURNED TEST STRIPS EVALUATED WITH DEFECT FOUND. QC INVESTIGATION ON 6/22/2017 RESULTED IN DEFECT FOUND; RETURNED TEST STRIPS PRODUCE LOW AND HIGH READINGS AND THE EVENT WAS DETERMINED TO BE REPORTABLE. MOST LIKELY UNDERLYING ROOT CAUSE OF OUT OF SPEC READINGS ARE DUE TO IMPROPER STORAGE: VIAL LEFT OPEN FOR AN EXTENDED PERIOD OF TIME. TEST STRIP UDI# (B)(4).

    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, 195 AND 188 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 - 150 MG/DL. AT THE TIME OF THE CALL ON (B)(6) 2017, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. CUSTOMER WAS APPLYING THE BLOOD INCORRECTLY. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE AT TIME OF CALL IS ONE - TWO WEEKS. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 195MG/DL (B)(6) 2017 11:29 PM FASTING:NO, THE 167MG/DL (B)(6) 2017 11:35 AM FASTING:YES, THE 159MG/DL (B)(6) 2017 11:30 AM FASTING:YES, THE 188MG/DL (B)(6) 2017 11:34 AM FASTING:YES, THE 148MG/DL (B)(6) 2017 11:50 AM FASTING:YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496302 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1796 00011822590051

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR