BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9337145 · Received November 18, 2019

    Report

    Report Number
    1000113657-2019-10165
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 24, 2019
    Report Date
    November 18, 2019
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THAT THE CUSTOMER'S CONDITION IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED CONDITION DID IMPROVE AND CUSTOMER DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED REPLACEMENT PRODUCT RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 199, 213, 169 AND 202 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER STATED THAT HE WAS FEELING CLAMMY AND SHAKY. MEDICAL ATTENTION WAS NOT REQUIRED AT THE TIME OF THE CALL. 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 19-JUL-2020. 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 (DATE/TIME NOT SET): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130418 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 MV3105S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1