BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 13005949 · Received December 14, 2021

    Report

    Report Number
    1000113657-2021-00777
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 14, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED - REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-058: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 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 18-NOV-2021 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HER CONDITION HAD IMPROVED AND SHE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 01-DEC-2021 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 309, 290, 296, 251, 241, 202 AND 228MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-120MG/DL AND EXPECTED PM FASTING) BLOOD GLUCOSE TEST RESULT RANGE IS 218-223MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING SHAKY AND WEAK; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. THE CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. 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 02/27/2023 AND OPEN VIAL DATE IS 11/17/2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 309 MG/DL DATE: 11/17/2021 TIME: 1002AM NON- FASTING , RESULT 2: 290 MG/DL DATE: 11/17/2021 TIME: 922AM NON- FASTING, RESULT 3: 296 MG/DL DATE: 11/17/2021 TIME: 920AM NON- FASTING, RESULT 4: 251 MG/DL DATE: 11/17/2021 TIME: 739AM NON- FASTING, RESULT 5: 241 MG/DL DATE: 11/17/2021 TIME: 715AM FASTING, RESULT 6: 202 MG/DL DATE: 11/16/2021 TIME: 654PM FASTING , RESULT 7: 228 MG/DL DATE: 11/16/2021 TIME: 638PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895943 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, GNP TMX 50CT MMMG/DL MY4464S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown