BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6825628 · Received August 28, 2017

    Report

    Report Number
    1000113657-2017-01621
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 28, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00011822590051
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER MEMORY OF 251, 169, 156, 184 AND 165 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 120 MG/DL. AT THE TIME OF THE CALL ON (B)(6) 2017, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2017 WHILE EATING, HER SUGAR HAD DROPPED AND SHE HAD PASSED OUT. CUSTOMER STATED THAT HER HUSBAND HAD TO CALL THE EMTS; WHEN THE EMTS CAME THEY PERFORMED A BLOOD TEST ON THE CUSTOMER AND OBTAINED A RESULT OF 17 MG/DL. THE EMTS GAVE THE CUSTOMER AN IV, PERFORMED ANOTHER BLOOD TEST AND OBTAINED A RESULT OF 28 MG/DL. THE EMTS THEN TOOK THE CUSTOMER TO THE HOSPITAL. WHEN CUSTOMER ARRIVED AT THE HOSPITAL SHE WAS TOLD HER BLOOD GLUCOSE WAS STILL LOW (CUSTOMER IS NOT SURE WHAT THE RESULTS WERE WHEN SHE ARRIVED AT THE HOSPITAL). BLOOD TEST PERFORMED WHILE AT THE HOSPITAL PRODUCED RESULT OF 249 MG/DL. CUSTOMER WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY (B)(6) 2017. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 186 MG/DL AND 189 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/23/2018 AND OPEN VIAL DATE IS 08/07/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: CUSTOMER IS CONCERN WITH ALL THESE RESULTS. CUSTOMER STATES THAT SHE DOES NOT THINK THE RESULTS SHE HAS BEEN GETTING ARE CORRECT. CUSTOMER STATES THAT SINCE SHE HAS BEEN SICK AND THE RESULTS HAVE BEEN HIGH. CUSTOMER HAS UPPER RESPIRATORY AND INFECTION AND SHE HAS THE FLU. CUSTOMER IS NOT HAVING ANY SYMPTOMS PERTAINING TO HER DIABETES AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604354 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MU2406 00011822590051

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR