BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8340691 · Received February 14, 2019

    Report

    Report Number
    1000113657-2019-00130
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 23, 2019
    Report Date
    February 14, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007928
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. CUSTOMER DECLINED REPLACEMENT PRODUCT AT THIS TIME. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4) USER'S TEST STRIP HAD POOR STORAGE (BATHROOM). 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 AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 183, 196 AND 200 MG/DL AND FROM BACK TO BACK BLOOD TESTS PERFORMED DURING THE CALL OF 199 AND 191 MG/DL. CUSTOMER WAS ALSO COMPARING RESULTS TO ANOTHER TRUEMETRIX METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 170 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/27/2019 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:191MG/DL, TIME:1207PM, DATE:(B)(6), FASTING; RESULT 2:199MG/DL, TIME:1206PM, DATE: (B)(6), FASTING; RESULT 3:183MG/DL, TIME 1110A, DATE: (B)(6) FASTING; RESULT 4:196MG/DL, TIME 1107A, DATE: (B)(6) FASTING; RESULT 5:200MG/DL, TIME 1105A, DATE: (B)(6) FASTING. CUSTOMER ORIGINALLY CONCERNED WITH BACK TO BACK READINGS. CUSTOMER WAS NOT USING PROPER TECHNIQUES, CUSTOMER WAS ALSO COMPARING TWO METERS BOTH TRUE METRIX. STRIPS WERE STORED IN THE BATHROOM. CUSTOMER ADVISED OF STORAGE. CUSTOMER WALKED THROUGH A BLOOD TEST AND OBTAINED READINGS OF 199MG/DL AND 191MG/DL FASTING. CUSTOMER STATED THAT HER BLOOD SUGAR HAS BEEN HIGH OVER A COURSE OF TIME, CUSTOMER LAST A1C WAS 7.4%. WHILE COLLECTING CUSTOMER INFORMATION THE PHONE WAS DISCONNECTED. CUSTOMER TO CALL BACK FOR STRIPS AND CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131713 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV2872 00021292007928

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR