BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6106130 · Received November 16, 2016

    Report

    Report Number
    1000113657-2016-01865
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 19, 2016
    Report Date
    November 16, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT SYSTEM EVALUATED WITH NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIPS HAD A POOR STORAGE(BATHROOM). MANUFACTURER CONTACTED CUSTOMER WITHIN 24 HOURS URGENT CALL AS WELL AS FOLLOW UP PHONE CALLS TO KNOW WHETHER CUSTOMER HAS HYPERGLYCEMIA SYMPTOMS AS REPORTED ON THE INITIAL CALL, HAD ON (B)(6) 2016; UNABLE TO MAKE CONTACT WITH CUSTOMER; SEVERAL FOLLOW UP PHONE CALLS ATTEMPTS MADE;UNABLE TO TALK TO CUSTOMER. LETTER SENT.

    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 172, 190 AND 210MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75MG/DL- 110MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION, CUSTOMER STORES THE PRODUCT IN THE BATHROOM. 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 190 AND 210MG/DL. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/27/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY:(TIME/DATE NO SET CORRECTLY: (B)(6). MEMORY CONCERN: HIGH RESULTS. CUSTOMER EDUCATED OF THE PRODUCT SYSTEM PROPER STORAGE ENVIRONMENTAL CONDITIONS. CUSTOMER STATES THAT HAD HYPERGLYCEMIC ATTACK ON (B)(6) 2016 A WEEK AGO. CUSTOMER WENT TO DOCTOR'S OFFICE; CUSTOMER TREATED WITH INSULIN. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757417 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1781

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY