BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 8445920 · Received March 22, 2019

    Report

    Report Number
    1000113657-2019-00243
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    February 27, 2019
    Report Date
    March 22, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007720
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. CUSTOMER DECLINED REPLACEMENT PRODUCT AT THIS TIME. CUSTOMER WAS COMFORTABLE WITH THE RESULTS FROM THE BACK TO BACK TESTING AND THE CONTROL SOLUTION TESTING. PRODUCT IS WORKING AS DESIGNED. 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 (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE INITIAL CONCERN WAS RESOLVED- UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE.

    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 161, 184, 214 AND 245 MG/DL. CUSTOMER STATED THAT SHE WAS ADVISED BY HER DOCTOR THAT HER BLOOD GLUCOSE RESULTS WOULD A LITTLE ELEVATED DUE TO HER A1C LEVEL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 MG/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. DURING THE CALL ON (B)(6) 2019, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 174 MG/DL AND 168 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND TEST STRIPS WERE OPENED THREE MONTHS AGO. CUSTOMER IS COMFORTABLE WITH THE RESULTS FROM THE BACK TO BACK TESTING AND THE CONTROL SOLUTION TEST. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CONCERNED WITH THE HIGH RESULTS THAT SHE IS GETTING FROM HER METER. CUSTOMER HAS NOT HAD ANY CHANGES TO HER DIET, EXERCISE OR LIFESTYLE ROUTINE. CUSTOMER STATED THAT HER DOCTOR TOOK HER OFF HER JANUVIA AND HER ZETIA ON (B)(6) 2019 AND THEN PUT HER BACK ON BOTH MEDICATIONS ON (B)(6) 2019. CUSTOMER STATED THAT HER LAST A1C WAS 7.6 ON (B)(6) 2019. CUSTOMER STATED THAT SHE WAS ADVISED BY HER DOCTOR THAT HER BLOOD GLUCOSE RESULTS WOULD A LITTLE ELEVATED DUE TO HER A1C LEVEL. CUSTOMER IS COMFORTABLE WITH THE RESULTS FROM THE BACK TO BACK TESTING AND THE CONTROL SOLUTION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236092 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MU2677 00021292007720

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR