BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9732768 · Received February 20, 2020

    Report

    Report Number
    1000113657-2020-00091
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    January 22, 2020
    Report Date
    March 26, 2020
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 26-MAR-2020: H6: UPDATED FDA'S METHOD, RESULT, AND CONCLUSION CODES. H10: METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED AND PASSED. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED REPLACEMENT PRODUCT RESOLVED INITIAL CONCERN.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM AM RESULT OBTAINED OF 166 MG/DL AND PM RESULTS OBTAINED OF 202, 152 AND 153 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH RESULT OBTAINED OF 182 MG/DL; CUSTOMER COULD NOT SEE THE TIME BUT STATED SHE EXPECTED TO GET 115 -130 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-110 MG/DL AND PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 115 - 130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT WHEN SHE HAD OBTAINED THE RESULT OF 202 MG/DL, SHE HAD TAKEN ONE TABLET OF METFORMIN 500 MG. CUSTOMER STATED THAT 30 MINUTES LATER SHE HAD FELT SYMPTOMS OF LOW BLOOD GLUCOSE: SHAKY, WEAK, HEADACHE, FEELING FAINT, AND DRY MOUTH. CUSTOMER STATED SHE HAD TESTED WITH ANOTHER DEVICE AND HAD OBTAINED A RESULT OF 69 MG/DL. CUSTOMER STATED THAT SHE HAD DRANK A SWEET DRINK AND FELT BETTER ABOUT 30 MINUTES LATER. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 109 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2021 AND OPEN VIAL DATE IS 01/15/2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 202MG/DL DATE: (B)(6) 2020 TIME: 4:00PM FASTING. RESULT 2 : 182MG/DL DATE: (B)(6) 2020 TIME: N/A FASTING. RESULT 3 : 152MG/DL DATE: (B)(6) 2020 TIME: 12:49PM FASTING. RESULT 4 : 166MG/DL DATE: (B)(6) 2020 TIME: 6:00AM FASTING. RESULT 5 : 153MG/DL DATE: (B)(6) 2020 TIME: 8:45PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194407 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX MJR 50CT12/CASE MG/DL MW3493S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1