BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11653539 · Received April 12, 2021

    Report

    Report Number
    1000113657-2021-00248
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 14, 2021
    Report Date
    April 12, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED FOR EVALUATION. REPORTED DEFECT NOT REPRODUCED.-NO DEFECT FOUND. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-012 PRODUCT EXPIRED. USE/STORAGE-USE OF EXPIRED PRODUCT NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 24-MAR- 2021 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED IS COMFORTABLE WITH THE RESULTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR E-0 ERROR. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM AND LIVING ROOM. THE CUSTOMER'S TEST STRIPS ARE EXPIRED: MANUFACTURER'S EXPIRATION DATE IS 01/31/2021. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER REPORTED THAT ON (B)(6) 2021, HE HAD BEEN FEELING ILL WITH SYMPTOMS OF HEADACHE, DIARRHEA AND VOMITING. CUSTOMER HAD GONE TO THE ER, WHERE HE HAD BLOOD DRAWN AND A URINE SAMPLE TAKEN. CUSTOMER'S BLOOD GLUCOSE TEST RESULT (VIA URINE TEST) WHEN AT THE ER HAD BEEN 396MG/DL (FASTING/NON-FASTING UNKNOWN). CUSTOMER HAD BEEN DIAGNOSED WITH AN ELEVATED BLOOD SUGAR LEVEL; CUSTOMER STATED NO MEDICAL TREATMENT WAS ADMINISTERED. CUSTOMER STATED THAT HE WAS GIVEN METFORMIN TO TAKE IN ADDITION TO HIS GLIPIZIDE AND WAS ADVISED TO FOLLOW-UP WITH HIS PRIMARY CARE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551196 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL MW3449S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization