BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 13094225 · Received December 28, 2021

    Report

    Report Number
    1000113657-2021-00798
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 28, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER: (B)(4): SAME TEST STRIP LOT NUMBER, DIFFERENT METER SERIAL NUMBER. METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. TEST STRIPS ARE EXPIRED - UNABLE TO TEST. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-006: PASSED EXPIRATION DATE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2021 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 HIGH BLOOD GLUCOSE TEST RESULTS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 185, 225, 231, 232 AND 208 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 110 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 120 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 BEDROOM. THE CUSTOMER'S TEST STRIPS ARE EXPIRED: TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/29/2021. 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 (DATE/TIME NOT SET): RESULT 1:185 MG/DL DATE: (B)(6) 2021 TIME: 2:08 PM FASTING, RESULT 2: 225 MG/DL DATE: (B)(6) 2021 TIME: 9:36 PM FASTING, RESULT 3: 231 MG/DL DATE: (B)(6) 2021 TIME: 4:25 AM FASTING, RESULT 4: 232 MG/DL DATE: (B)(6) 2021 TIME: 12:00 AM FASTING, RESULT 5: 208 MG/DL DATE: (B)(6) 2021 TIME: 11:49 PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000694 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX CVS 100CT12/CASE MG/DL MX4223S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown