BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 19817017 · Received July 24, 2024

    Report

    Report Number
    1000113657-2024-00310
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    June 28, 2024
    Report Date
    July 24, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO METER RESULTS. METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER AND TEST STRIPS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING 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. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2024 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HIS CONDITION HAD IMPROVED AND HE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2024 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Additional Manufacturer Narrative · 0

    CORRECTED SECTIONS AS OF 24-JUL-2024: H1: TYPE OF REPORTABLE EVENT CORRECTED FROM "MALFUNCTION" TO "SERIOUS INJURY" DUE TO NO DEFECT FOUND ON RETURNED METER AND TEST STRIPS.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 233, 288, 322, 277 AND 297 MG/DL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF "FOGGY BRAIN" AND FEELING TIRED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT ON (B)(6) 2024 HE WENT TO THE DOCTOR DUE TO THE METER RESULTS. CUSTOMER HAD TESTED USING ANOTHER DEVICE WHEN AT THE DOCTOR'S OFFICE AND STATED THE RESULT HAD BEEN ABOUT 150 POINTS LOWER; CUSTOMER DID NOT DISCLOSE THE RESULT. DOCTOR HAD ADVISED THE CUSTOMER TO OBTAIN A NEW METER. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/27/2025 AND OPEN VIAL DATE IS (B)(6) 2024. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1: 233 MG/DL DATE: (B)(6) 2024 TIME: 11:46 PM FASTING PM RESULT 2: 288 MG/DL DATE: (B)(6) 2024 TIME :5:22 PM FASTING PM RESULT 3: 322 MG/DL DATE: (B)(6) 2024 TIME: 5:03 PM FASTING PM RESULT 4: 277 MG/DL DATE: (B)(6) 2024 TIME: 2:29 PM FASTING PM RESULT 5: 297 MG/DL DATE: (B)(6) 2024 TIME: 11:09 AM FASTING PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370584 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL ZC5669S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other