BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9235037 · Received October 24, 2019

    Report

    Report Number
    1000113657-2019-10096
    Event Type
    Malfunction
    Date Received
    October 24, 2019
    Date of Event
    September 30, 2019
    Report Date
    May 1, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). SECTIONS WITH ADDITIONAL INFORMATION AS OF 01-MAY-2020: 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. CORRECTED SECTIONS AS OF 01-MAY-2020: H3: DEVICE WAS RETURNED TO MANUFACTURER FOR EVALUATION CORRECTED FROM "YES" TO "NO".

    Additional Manufacturer Narrative · 1

    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 CUSTOMER'S 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 AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 161, 184 AND 164 MG/DL. RESULTS WERE OBTAINED USING AN OLD VIAL OF TEST STRIPS, LOT NUMBER MW3425S, MANUFACTURER¿S EXPIRATION DATE IS 01/17/2021. CUSTOMER STATED SHE OPENED A NEW VIAL TODAY, LOT NUMBER MV3015, MANUFACTURER'S EXPIRATION DATE OF 05/23/2020. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125 - 140 MG/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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 181 MG/DL AND 177 MG/DL USING METER. CUSTOMER WAS SATISFIED WITH BACK TO BACK TEST. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DRESSER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME IS NOT SET): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029503 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS 50CT 360/CS MG/DL MW3425S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1