BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 11390867 · Received February 28, 2021

    Report

    Report Number
    1000113657-2021-00155
    Event Type
    Injury
    Date Received
    February 28, 2021
    Date of Event
    February 3, 2021
    Report Date
    April 19, 2021
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 19-APR-2021: H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. 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 WITHIN SPECIFICATIONS MOST LIKELY UNDERLINE ROOT CAUSE MLC-055 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.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO SYMPTOMS RELATED TO DIABETES ¿ WEAK AND TIRED. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE CUSTOMER'S CONDITION IMPROVED AND 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 BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 199, 151, 197, 198 AND 186 MG/DL. CUSTOMER WAS CONCERNED ABOUT THE RESULTS FROM THE METER DID NOT MATCH THE RESULTS FROM DOCTOR'S DEVICE (SCHEDULED APPOINTMENT); ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-130 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING WEAK AND TIRED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION (BEDROOM). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/15/2022 AND CUSTOMER DID NOT RECALL THE OPEN VIAL DATE. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET; ALL ARE AM RESULTS): RESULT 1: 199 MG/DL, DATE: (B)(6) 2021 TIME: 8:19PM, FASTING; RESULT 2: 151 MG/DL, DATE: (B)(6) 2021 TIME: 10:02PM, FASTING; RESULT 3: 197 MG/DL, DATE: (B)(6) 2021 TIME: 10:56PM, FASTING; RESULT 4: 198 MG/DL, DATE: (B)(6) 2021 TIME: 6:37PM, FASTING; RESULT 5: 186 MG/DL, DATE: (B)(6) 2021 TIME: 10:20PM, FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287757 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZX4234S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other