BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6667183 · Received June 26, 2017

    Report

    Report Number
    1000113657-2017-01088
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Date of Event
    June 2, 2017
    Report Date
    June 26, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007010
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT # (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. THE CUSTOMER IS CONCERNED WITH THE RESULTS OBTAINED OF 317, 335, 222 AND 188MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 170MG/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. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 335 AND 317MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/17/2018 AND OPEN VIAL DATE IS LESS THAN A MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): THE 222MG/DL (B)(6) 2017 03:12:00 PM FASTING: YES, THE 188MG/DL (B)(6) 2017 03:09:00 PM FASTING: YES, THE 131MG/DL (B)(6) 2017 09:09:00 AM FASTING: YES, THE 120MG/DL (B)(6) 2017 08:46:00 PM FASTING: YES, THE 116MG/DL (B)(6) 2017 07:55:00 AM FASTING: YES. MEMORY CONCERNS: CUSTOMER WAS CALLING BECAUSE HE WAS CONCERNED ABOUT THE RESULTS THAT HE WAS GETTING FROM HIS METER. HE STATES THAT THE RESULTS ARE HIGHER THAN WHAT HE IS USED TO WHICH IS BETWEEN 80-170MG/DL WHILE FASTING. I DID HAVE THE CUSTOMER DO A BACK TO BACK TEST WITH ME AND THE RESULTS WERE WITHIN NORMAL LIMITS. SEE BELOW FOR DETAILS: -1ST RESULT: 335MG/DL @ 12:41PM {F} LH - IF, -2ND RESULT: 317MG/DL @ 12:49PM {F} LH - MF. CUSTOMER WAS NOT SATISFIED WITH THE BACK TO BACK TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449213 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MU2356 00021292007010

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR