BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 9336322 · Received November 18, 2019

    Report

    Report Number
    1000113657-2019-10163
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 22, 2019
    Report Date
    May 11, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). SECTIONS WITH ADDITIONAL INFORMATION AS OF 11-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. CORRECTED SECTIONS AS OF 11-MAY-2020: H3: DEVICE WAS RETURNED TO MANUFACTURER FOR EVALUATION CORRECTED FROM "YES" TO "NO"

    Additional Manufacturer Narrative · 1

    METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-62: USER HAD POOR TECHNIQUE. 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 HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 143, 163 AND 190 MG/DL; CUSTOMER STATED THAT THE TESTS WERE PERFORMED USING DIFFERENT HANDS (143MG/DL FASTING ON RIGHT HAND AND 163MG/DL AND 190MG/DL FROM HER LEFT HAND). AT THE TIME, CUSTOMER INITIALLY CALLED ON 12-OCT-2019, SHE DID NOT HAVE ANY TEST STRIPS TO TROUBLESHOOT. FOLLOW-UP CALL WAS MADE TO CUSTOMER ON 24-OCT-2019 AND CUSTOMER STATED SHE HAD OBTAINED A NEW VIAL, LOT MW3427S, MANUFACTURER'S EXPIRATION DATE IS 19-JAN-2021 AND OPEN VIAL DATE IS (B)(6) 2019. CUSTOMER STATED SHE WENT TO HER ROUTINE OB APPOINTMENT FOR AN ULTRASOUND. A BLOOD TEST WAS DONE 2 HRS FASTING AFTER A MEAL AND HER BLOOD GLUCOSE TEST RESULT WITH THEIR METER WAS 84 MG/DL FASTING. CUSTOMER STATED SHE HAS NEVER GOTTEN A RESULT THAT LOW WITH THE METER. CUSTOMER ALSO SOMETIMES USES ALCOHOL PADS AND WAS EDUCATED ON PROPER HAND WASHING TECHNIQUE, THE CUSTOMERS EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75 - 95 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 165 MG/DL AND 140 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131581 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 MW3427S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1