BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 8981422 · Received September 10, 2019

    Report

    Report Number
    1000113657-2019-00897
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 14, 2019
    Report Date
    April 29, 2020
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007720
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) SECTIONS WITH ADDITIONAL INFORMATION AS OF 29-APR-2020: 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. INTERNAL REPORT # (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. TEST STRIPS UDI: (B)(4). 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 · 0

    CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 101, 141, 70, 90 AND 100 MG/DL; TESTS WERE DONE USING THE SAME HAND, DIFFERENT FINGER. CUSTOMER WAS NOT CONCERNED WITH THE RESULT OF 70 MG/DL BEING LOW. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 - 100 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 102 MG/DL AND 82 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM/LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/13/2020 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 101MG/DL, DATE: (B)(6) 2019, TIME: 1240PM, FASTING. RESULT 2: 141MG/DL, DATE: (B)(6) 2019, TIME: 1239PM, FASTING. RESULT 3: 70MG/DL, DATE: (B)(6) 2019, TIME: 1237PM, FASTING. RESULT 4: 90MG/DL, DATE: (B)(6) 2019, TIME: 12.33PM, FASTING. RESULT 5: 100MG/DL, DATE: (B)(6) 2019, TIME: 12:30PM, FASTING.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (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. TEST STRIPS UDI: (B)(4). 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 ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 101, 141, 70, 90 AND 100 MG/DL; TESTS WERE DONE USING THE SAME HAND, DIFFERENT FINGER. CUSTOMER WAS NOT CONCERNED WITH THE RESULT OF 70 MG/DL BEING LOW. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 - 100 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 102 MG/DL AND 82 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM/LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/13/2020 AND OPEN VIAL DATE IS 08/14/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777248 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MV2996 00021292007720

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY| SECOND THERAPY