BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 17475870 · Received August 7, 2023

    Report

    Report Number
    1000113657-2023-00410
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 12, 2023
    Report Date
    September 19, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 19-SEPT-2023: H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS RETURNED FOR EVALUATION: REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. PRODUCT EVALUATION HAS BEEN COMPLETED AND MOST LIKELY UNDERLYING ROOT CAUSE SELECTED. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). 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 UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 17-JUL-2023 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR LOW AND HIGH BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGES (E-2 AND E-3). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 183, 40, 211 AND 246 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 82-116 MG/DL AM FASTING, 149-165 MG/DL PM FASTING AND 165-211 MG/DL BEDTIME FASTING. 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/25/2024 AND OPEN VIAL DATE IS TWO WEEKS AGO. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY; CUSTOMER PROVIDED RESULTS FROM HER NOTES: AM FASTING: 183 MG/DL, (B)(6) 2023. 101 MG/DL, (B)(6) 2023. 82 MG/DL, (B)(6) 2023. 89 MG/DL, (B)(6) 2023. PM FASTING: 211 MG/DL, (B)(6) 2023. 149 MG/DL, (B)(6) 2023. 246 MG/DL, (B)(6) 2023. BEDTIME FASTING: 165 MG/DL, (B)(6) 2023. 195 MG/DL, (B)(6) 2023. 197 MG/DL, (B)(6) 2023. 210 MG/DL, (B)(6) 2023. 211 MG/DL, (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279776 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT 12/CS MG/DL #383569 ZB5221S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown