BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9560417 · Received January 7, 2020

    Report

    Report Number
    1000113657-2020-00010
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 9, 2019
    Report Date
    January 7, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20: USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 233, 171, 218, 226 AND 281 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 130 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, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/30/2021. CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 233 MG/DL DATE: (B)(6) 2019 TIME: 8:05 AM FASTING . RESULT 2: 171 MG/DL DATE: (B)(6) 2019 TIME: 4:48 PM FASTING . RESULT 3: 218 MG/DL DATE: (B)(6) 2019 TIME: 3:58 PM FASTING . RESULT 4: 226 MG/DL DATE: (B)(6) 2019 TIME: 3:42 PM FASTING . RESULT 5: 281 MG/DL DATE: (B)(6) 2019 TIME: 3:20 PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22521 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 MW4028S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1