BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 8916951 · Received August 21, 2019

    Report

    Report Number
    1000113657-2019-00840
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    July 29, 2019
    Report Date
    May 14, 2020
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) SECTIONS WITH ADDITIONAL INFORMATION AS OF 14-MAY-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. INTERNAL REPORT # (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-57: USER HAD AN INACCURATE REFERENCE: ALTERNATE METER: THE END USER IS COMPARING RESULTS OBTAINED FROM ONE OF TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM ANOTHER TRIVIDIA'S BGM SYSTEM. TEST STRIPS UDI: (B)(4). 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.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 248, 133, 152, 125 AND 118 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH TEST RESULTS FROM METER TO METER COMPARISON OF 248 MG/DL USING PERSONAL METER AND 93 MG/DL USING ALTERNATIVE METER. CUSTOMER WAS USING EXPIRED TEST STRIPS WHEN TESTING WITH ALTERNATIVE METER (MANUFACTURER'S EXPIRATION DATE OF 12/22/2018). THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 - 113 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 NON-FASTING AND PRODUCED TEST RESULTS OF 92 MG/DL AND 101 MG/DL USING PERSONAL METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/26/2020 AND TEST STRIPS WERE OPENED ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 248MG/DL, DATE:(B)(6) 2019, TIME:12:01PM FASTING. RESULT 2: 133MG/DL, DATE:(B)(6) 2019, TIME:09:25PM FASTING. RESULT 3: 152MG/DL, DATE:(B)(6) 2019, TIME:12:00PM FASTING. RESULT 4: 125MG/DL, DATE:(B)(6) 2019, TIME:06:00PM FASTING. RESULT 5: 118MG/DL, DATE:(B)(6) 2019, TIME:07:29PM FASTING.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-57: USER HAD AN INACCURATE REFERENCE: ALTERNATE METER: THE END USER IS COMPARING RESULTS OBTAINED FROM ONE OF TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM ANOTHER TRIVIDIA'S BGM SYSTEM. TEST STRIPS UDI: (B)(4). 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.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 248, 133, 152, 125 AND 118 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH TEST RESULTS FROM METER TO METER COMPARISON OF 248 MG/DL USING PERSONAL METER AND 93 MG/DL USING ALTERNATIVE METER. CUSTOMER WAS USING EXPIRED TEST STRIPS WHEN TESTING WITH ALTERNATIVE METER (MANUFACTURER'S EXPIRATION DATE OF 12/22/2018). THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 - 113 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 NON-FASTING AND PRODUCED TEST RESULTS OF 92 MG/DL AND 101 MG/DL USING PERSONAL METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/26/2020 AND TEST STRIPS WERE OPENED ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710130 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MW3330S

    Patients

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