BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 10557041 · Received September 18, 2020

    Report

    Report Number
    1000113657-2020-00688
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 21, 2020
    Report Date
    October 7, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007720
    PMA / PMN Number
    K150052
    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 07-OCT-2020: H6: UPDATED FDA'S METHOD, RESULT, AND CONCLUSION CODES. H10: METER WAS RETURNED FOR EVALUATION; NO DEFECT WAS DETECTED. TEST STRIPS WERE RETURNED FOR EVALUATION; NO DEFECT WAS DETECTED.

    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 ON 01-SEP-2020 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED. THE INITIAL CONCERN ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED REPLACEMENT PRODUCT HAS NOT BEEN USED YET.

    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 256, 398, 464, 387 AND 320 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200-265 MG/DL AND BEDTIME FASTING BLOOD GLUCOSE TEST RESULT IS 200 MG/DL. CUSTOMER HAD GONE TO A ROUTINE DOCTOR'S VISIT ON DAY OF CALL. CUSTOMER STATED SHE SOMETIMES HAS A HEADACHE 2-3 TIMES A WEEK THAT MAY BE RELATED TO HER DIABETES AND THAT HER PHYSICIAN IS AWARE OF THIS. AT THE TIME TECHNICIAN SPOKE WITH THE CUSTOMER, THE CUSTOMER FELT FINE AND DID NOT REPORT ANY SYMPTOMS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2021 AND CUSTOMER WAS UNSURE OF THE OPEN VIAL DATE. 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 (TIME/DATE WAS JUST SET ON DAY OF CALL): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017217 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC KIT, AIR TVH TMX NFRSSTARTER MG/DL MW4118S 00021292007720

    Patients

    Seq Age Sex Outcome Treatment
    1