BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 7641784 · Received June 27, 2018

    Report

    Report Number
    1000113657-2018-00690
    Event Type
    Malfunction
    Date Received
    June 27, 2018
    Date of Event
    June 1, 2018
    Report Date
    June 27, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007447
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. TEST STRIP UDI# (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER ON (B)(6) 2018 IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION OR SYMPTOMS SINCE THE LAST CALL.

    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 190, 277, 190, 408 AND 213 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 135 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2018 SHE HAD OBTAINED A RESULT OF 32 MG/DL FASTING AND WAS HAVING SYMPTOMS. CUSTOMER STATED SHE DOES NOT REMEMBER EXACTLY WHAT HAPPENED BECAUSE SHE WAS FEELING LOOPY AND SO SHE DID NOT RECALL ALL OF THE SYMPTOMS. CUSTOMER HAD CALLED THE PARAMEDICS AND CUSTOMER'S BLOOD GLUCOSE TEST RESULT USING THE PARAMEDIC'S METER WAS 46 MG/DL. THE PARAMEDICS DID NOT BRING THE CUSTOMER TO THE HOSPITAL; PARAMEDICS HAD THE CUSTOMER EAT AND STAYED WITH HER UNTIL HER BLOOD GLUCOSE TEST RESULT OBTAINED USING THEIR METER WAS 150 MG/DL NON-FASTING. CUSTOMER HAD CONTINUED TO USE THE TRUEMETRIX AIR METER AFTERWARDS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 91 MG/DL AND 142 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2018 AND OPEN VIAL DATE IS 06/01/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :190MG/DL DATE:(B)(6) 2018 TIME:09:02AM FASTING; RESULT 2 :277MG/DL DATE:(B)(6) 2018 TIME:10:24AM FASTING; RESULT 3 :190MG/DL DATE:(B)(6) 2018 TIME:12:33PM FASTING; RESULT 4 :408MG/DL DATE:(B)(6) 2018 TIME:02:34PM FASTING; RESULT 5 :213MG/DL DATE:(B)(6) 2018 TIME:07:30PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483073 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MU2416 00021292007447

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY