BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 18676236 · Received February 9, 2024

    Report

    Report Number
    1000113657-2024-00054
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 9, 2024
    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). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED FOR EVALUATION-REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-058: 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. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2023 TO ENSURE AND TO ENSURE THE CUSTOMER¿S INITIAL CONCERN WAS RESOLVED- THE CUSTOMER STATED SHE IS COMFORTABLE WITH THE GLUCOSE READINGS FROM THE REPLACEMENT PRODUCTS. .

    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 182, 186, 256, 274 AND 214 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 130 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 NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/30/2025 AND OPEN VIAL DATE IS ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1: 182 MG/DL , DATE: ON (B)(6)2024 , TIME: 1:00PM , FASTING PM . RESULT 2: 186 MG/DL, DATE: ON (B)(6) 2024 , TIME: 1:13PM , FASTING PM . RESULT 3: 256 MG/DL , DATE: ON (B)(6)2024 , TIME: ,12:56PM, FASTING AM. RESULT 4: 274 MG/DL , DATE: ON (B)(6)2024 , TIME: ,12:34AM , FASTING AM. RESULT 5: 214 MG/DL , DATE: ON (B)(6)2024 , TIME: ,9:54AM , FASTING AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338726 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT24/CASE MG/DL ZB5430S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown