BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 17956273 · Received October 18, 2023

    Report

    Report Number
    1000113657-2023-00512
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    September 25, 2023
    Report Date
    October 18, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007829
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO SYMPTOMS RELATED TO DIABETES: HEADACHE. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALLS ON 26-SEP-2023, 27-SEP-2023, 28-SEP-2023 AND 29-SEP-2023 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HE STILL HAD THE HEADACHE. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 03-OCT-2023 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HE STILL HAD THE HEADACHE. CUSTOMER STATED HE DID NOT CONTACT THE DOCTOR REGARDING THE HEADACHE. CUSTOMER STATED THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGES (E-2, E-3 AND E-1). THE CUSTOMER REPORTED HAVING A HEADACHE; MEDICAL ATTENTION WAS NOT NEEDED 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 (STORED IN CUSTOMER'S CAR). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2025 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203246 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 25CT24/CS MG/DL #383237 ZB5349S 00021292007829

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other