BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 19181276 · Received April 25, 2024

    Report

    Report Number
    1000113657-2024-00179
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    April 8, 2024
    Report Date
    April 25, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    0002129200783
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4) ADDITIONAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT PASSED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-057: USER HAD AN INACCURATE REFERENCE: ALTERNATE METER: THE END USER IS COMPARING RESULTS OBTAINED FROM ONE OF TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM ANOTHER TRIVIDIA¿S BGM SYSTEM. NOTE: 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 HE DID NOT RECEIVE THE REPLACEMENT PRODUCTS. CONFIRMED WITH THE CUSTOMER THAT ADDRESS ON FILE WAS CORRECT. CUSTOMER DECLINED TO HAVE ANOTHER REPLACEMENT PRODUCT SENT TO HIM. CUSTOMER DECLINED TO BE CONTACTED FURTHER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER REPORTED COMPLAINT FOR TWO TRUE METRIX METERS: ADDITIONAL INTERNAL REPORT REFERENCE NUMBER (B)(4). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 134, 142, 129, 160 AND 124 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-90 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 138 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/31/2025 AND TEST STRIPS WERE OPENED TWO WEEKS PRIOR TO THE CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 134 MG/DL, DATE: 04-07, TIME: 07:14 AM, FASTING. RESULT 2: 142 MG/DL, DATE: 04-07, TIME: 07:08 AM, FASTING. RESULT 3: 129 MG/DL , DATE: 04-07, TIME: 07:06 AM, FASTING. RESULT 4: 160 MG/DL , DATE: 04-06, TIME: 05:39 PM, FASTING. RESULT 5: 124 MG/DL , DATE: 04-06 , TIME: 09:09 AM, FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614578 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZB5576S 0002129200783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown