BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11653329 · Received April 12, 2021

    Report

    Report Number
    1000113657-2021-00246
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 17, 2021
    Report Date
    June 7, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 07-JUN-2021: H10: 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-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.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION - CUSTOMER DECLINED REPLACEMENT. ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER EXPERIENCING SYMPTOM (LIGHTHEADED) AFTER ADMINISTERING MEDICATION BASED ON THE HIGH BLOOD GLUCOSE TEST RESULT OBTAINED. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 30-MAR-2021 TO ENSURE THE INITIAL CONCERN WAS RESOLVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HE IS COMFORTABLE WITH THE RESULTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 142, 144, 126, 163 AND 156 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 120 MG/DL; AN EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE WAS NOT PROVIDED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED A FEW DAYS PRIOR TO CALL HE HAD OBTAINED A RESULT OF 225 MG/DL (FASTING/NON-FASTING STATUS UNKNOWN) AND HAD ADMINISTERED 9 UNITS OF INSULIN. CUSTOMER STATED HE HAD TESTED 30 MINUTES LATER AND OBTAINED A RESULT OF 59 MG/DL NON-FASTING AND THAT HE HAD BEEN FEELING LIGHTHEADED AT THE TIME. CUSTOMER STATED HE HAD DRANK SOME ORANGE JUICE, ATE A PUDDING CUP, AND HAD RE-TESTED AND OBTAINED A RESULT OF 157 MG/DL NON-FASTING. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOM. THE CUSTOMER DECLINED TO PERFORM A BACK BLOOD TEST DURING THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/24/2022 AND TEST STRIPS WERE OPENED THREE WEEKS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550932 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, LEADER TMX 50CTMM MG/DL ZX4149S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other