BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 10167180 · Received June 18, 2020

    Report

    Report Number
    1000113657-2020-00411
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 20, 2020
    Report Date
    July 20, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 20-JUL-2020: H6: UPDATED FDA'S METHOD, RESULT, AND CONCLUSION CODES. H10: METER WAS RETURNED FOR EVALUATION; NO DEFECT WAS DETECTED. TEST STRIPS WERE RETURNED FOR EVALUATION; NO DEFECT WAS DETECTED.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-55: USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM 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 ARRIVED BUT HAS NOT BEEN USED. CUSTOMER STATED SHE WILL CALL BACK ONCE SHE USES THE REPLACEMENT PRODUCT.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. DAUGHTER CALLED ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 192, 220, 209, 205 AND 196 MG/DL; THE RESULTS OF 192 AND 205 MG/DL WERE NON-FASTING. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 99-131 MG/DL; AN EXPECTED NON-FASTING RANGE WAS NOT PROVIDED. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. AT THE TIME OF THE CALL, THE CUSTOMER WAS FEELING WELL AND DID NOT HAVE ANY SYMPTOMS. CUSTOMER STATED THAT SHE WOKE UP AT 9AM NOT FEELING WELL. CUSTOMER HAS CHRONIC KIDNEY ISSUES AND SOMETIMES DOES NOT FEEL WELL. CUSTOMER WAS NOT SURE IF HER GLUCOSE LEVELS WERE LOW, SHE DRANK ORANGE JUICE, AND TESTED AFTERWARDS. CUSTOMER OBTAINED 205MG/DL NON-FASTING AND 2HRS LATER 209 MG/DL FASTING. CUSTOMER DECIDED TO TAKE 1/2 TAB OF HER GLYBURIDE AND ATE SALAD OUT OF FEAR HER GLUCOSE WOULD DROP. CUSTOMER GOT WORRIED AND CALLED THE PARAMEDICS BECAUSE SHE FELT THE TRUEMETRIX AIR METER WAS NOT READING ACCURATELY. A FASTING METER TO METER COMPARISON WAS PERFORMED WITH RESULTS OBTAINED OF 164 MG/DL WITH PARAMEDICS METER AND 220 MG/DL WITH TRUEMETRIX AIR METER; CUSTOMER WAS ALSO CONCERNED WITH THE METER TO METER COMPARISON. NO DIAGNOSIS OR MEDICAL TREATMENT WAS GIVEN TO CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. CUSTOMER HAD ANOTHER VIAL OF TEST STRIPS THAT WAS STORED AND HANDLED CORRECTLY, LOT NUMBER MV3047S, MANUFACTURER'S EXPIRATION DATE OF 05/31/2020. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 182 MG/DL AND 179 MG/DL USING TRUEMETRIX AIR METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME/DATE NOT SET): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634429 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL MW3460S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention