BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 14363167 · Received May 11, 2022

    Report

    Report Number
    1000113657-2022-00278
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    March 22, 2022
    Report Date
    May 11, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TEST WAS PERFORMED AND DEFECT FOUND ON RETURNED TEST STRIPS: HIGH RESULTS. NO DEFECT FOUND ON RETURNED METER. ROOT CAUSE: RC-061: STORAGE OUTSIDE SPECIFICATIONS. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2022 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 HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 162, 172, 136, 149 AND 143MG/DL. CUSTOMER STATED THE RESULTS USING THE TRUE METRIX METER WERE HIGHER THAN ANOTHER DEVICE (NO METER TO METER COMPARISON RESULTS WERE PROVIDED). THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 102-112MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2023 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 162MG/DL DATE: (B)(6) TIME: 12:44AM FASTING, RESULT 2 : 172MG/DL DATE: (B)(6) TIME: 6:09AM FASTING, RESULT 3 : 136MG/DL DATE: (B)(6) TIME: 5:23AM FASTING, RESULT 4 : 149MG/DL DATE: (B)(6) TIME: 5:23AM FASTING, RESULT 5 : 143MG/DL DATE: (B)(6) TIME: 5:20AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239528 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX AID 50CT24/CASE MG/DL ZY4495S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown