BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 16156745 · Received January 13, 2023

    Report

    Report Number
    1000113657-2023-00018
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 21, 2022
    Report Date
    February 14, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007720
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO SYMPTOMS RELATED TO DIABETES: NUMBNESS IN HANDS. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-090: USER REMOVED BATTERY. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 14-FEB-2023: H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H10: TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR DEAD METER. COMPANY REPRESENTATIVE (WALMART) IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT THE BATTERY IN THE TRUE METRIX AIR METER HAD BEEN CHANGED BUT DID NOT INDICATE WHEN THAT HAD OCCURRED. THE CUSTOMER IS USING THE CORRECT BATTERY, IN THE CORRECT ORIENTATION FOR THE METER. DURING THE CALL THE TRUE METRIX AIR METER DID NOT POWER ON USING THE POWER BUTTON OR WHEN A TEST STRIP WAS INSERTED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/24/2023; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT DISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED THAT HER HANDS WERE NUMB; CUSTOMER STATED THAT THIS WAS AN INDICATION HER BLOOD GLUCOSE WAS LOW. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465302 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC KIT, RLN AIR TMX METERMG/DL ZA4818S 00021292007720

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other