BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 8358558 · Received February 21, 2019

    Report

    Report Number
    1000113657-2019-00144
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Date of Event
    January 29, 2019
    Report Date
    December 12, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE: T, CORRECTED DATA: F) INTERNAL REPORT#: (B)(4). METER WAS RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. TEST STRIPS WERE RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. 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. PATIENT CODE 3191 (ABOVE): NO CODE AVAILABLE - CUSTOMER REPORTED SYMPTOM OF LIGHTHEADED. NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 180, 263 AND 156 MG/DL FASTING AND OF 246 AND 341 MG/DL NON-FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 146 - 158 MG/DL AND NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 178 - 240 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING LIGHTHEADED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER STATED THAT SHE HAD OBTAINED A RESULT OF 246 MG/DL USING THE TRUEMETRIX AIR METER AND DUE TO THE RESULT BEING HIGH, HAD TAKEN 24 UNITS OF INSULIN PER DOCTOR'S ORDERS. CUSTOMER STATED SHORTLY THEREAFTER SHE BEGAN HAVING SYMPTOMS AND GOT VERY HOT AND FELT FAINT. CUSTOMER DID NOT SEEK ANY MEDICAL ATTENTION; CUSTOMER STATED SHE HAD EATEN A SPOON OF PEANUT BUTTER AND A BANANA AND ABOUT 15 MINUTES LATER HER SYMPTOMS WERE GONE. CUSTOMER DID NOT PERFORM A BLOOD GLUCOSE TEST WHEN SHE BEGAN TO HAVE SYMPTOMS OR AFTER THEY WERE GONE SO SHE WAS NOT AWARE WHAT HER BLOOD GLUCOSE WAS AT THAT TIME. DURING THE CALL ON (B)(6) 2019, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 329 MG/DL AND 342 MG/DL USING TRUEMETRIX AIR METER. CUSTOMER WAS NOT COMFORTABLE WITH THE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/27/2020 AND OPEN VIAL DATE IS 01/28/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:246MG/DL, DATE: ON (B)(6) 2019, TIME:10:10PM NON-FASTING, RESULT 2:341MG/DL, DATE: ON (B)(6) 2019, TIME:8:12AM NON-FASTING, RESULT 3:180MG/DL, DATE: ON (B)(6) 2019, TIME:10:56AM FASTING, RESULT 4:263MG/DL, DATE: ON (B)(6) 2019, TIME:9:08PM FASTING, RESULT 5:156MG/DL, DATE: ON (B)(6) 2019, TIME:10:43AM FASTING.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET 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. (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 180, 263 AND 156 MG/DL FASTING AND OF 246 AND 341 MG/DL NON-FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 146 - 158 MG/DL AND NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 178 - 240 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING LIGHTHEADED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER STATED THAT SHE HAD OBTAINED A RESULT OF 246 MG/DL USING THE TRUEMETRIX AIR METER AND DUE TO THE RESULT BEING HIGH, HAD TAKEN 24 UNITS OF INSULIN PER DOCTOR'S ORDERS. CUSTOMER STATED SHORTLY THEREAFTER SHE BEGAN HAVING SYMPTOMS AND GOT VERY HOT AND FELT FAINT. CUSTOMER DID NOT SEEK ANY MEDICAL ATTENTION; CUSTOMER STATED SHE HAD EATEN A SPOON OF PEANUT BUTTER AND A BANANA AND ABOUT 15 MINUTES LATER HER SYMPTOMS WERE GONE. CUSTOMER DID NOT PERFORM A BLOOD GLUCOSE TEST WHEN SHE BEGAN TO HAVE SYMPTOMS OR AFTER THEY WERE GONE SO SHE WAS NOT AWARE WHAT HER BLOOD GLUCOSE WAS AT THAT TIME. DURING THE CALL ON (B)(6) 2019, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 329 MG/DL AND 342 MG/DL USING TRUEMETRIX AIR METER. CUSTOMER WAS NOT COMFORTABLE WITH THE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/27/2020 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151792 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MV3071 00021292007836

    Patients

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