BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 17009757 · Received May 26, 2023

    Report

    Report Number
    1000113657-2023-00297
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    April 8, 2023
    Report Date
    May 26, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    000212920078
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-012: PRODUCT EXPIRED. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 18-MAY-2023 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HI AND HIGH BLOOD GLUCOSE TEST RESULTS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI, 497, 534 AND 421 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 230-534 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CAREGIVER STATED CUSTOMER HAD BEEN HOSPITALIZED (B)(6)2023 - (B)(6)2023 DUE TO HIGH BLOOD GLUCOSE (CAREGIVER DID NOT PROVIDE METER RESULTS). THE DIAGNOSIS WAS HIGH BLOOD GLUCOSE AND CUSTOMER WAS TREATED WITH INSULIN. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIPS ARE EXPIRED: TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/18/2023. THE 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 : HI DATE: 05-03 TIME: 11:27 AM FASTING RESULT 2 : HI DATE: 05-03 TIME: 11:26 AM FASTING RESULT 3 : 497 MG/DL DATE: 05-02 TIME: 12:08 PM FASTING RESULT 4 : 534 MG/DL DATE: 05-01 TIME: 11:26 AM FASTING RESULT 5 : 421MG/DL DATE: 04-28 TIME: 11:08 AM FASTING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718880 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL MY4448S 000212920078

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization