BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 12583731 · Received October 6, 2021

    Report

    Report Number
    1000113657-2021-00629
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 8, 2021
    Report Date
    October 15, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 15-OCT-2021: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND DEFECT FOUND ON RETURNED STRIPS: HIGH RESULTS. NO DEFECT FOUND ON RETURNED METER. ROOT CAUSE: RC-061: STORAGE OUTSIDE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED - PRODUCT EVALUATION IN-PROCESS. NOTE: MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 200, 203, 575 AND 256MG/DL. CUSTOMER STATED SHE WAS NOT HAVING ANY SYMPTOMS OF HYPERGLYCEMIA WHEN SHE TESTED AT 575MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 120MG/DL AND EXPECTED BLOOD GLUCOSE TEST RESULT ONE HOUR POST MEAL IS 135MG/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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 134MG/DL USING TRUE METRIX METER; CUSTOMER WAS NOT SATISFIED WITH THE RESULT OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/15/2022 AND TEST STRIPS WERE OPENED ONE WEEK PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485083 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 ZY4384S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1