BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11605608 · Received April 1, 2021

    Report

    Report Number
    1000113657-2021-00223
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 4, 2021
    Report Date
    May 11, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292012236
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 11-MAY-2021: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. 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. NOTE: MANUFACTURER CONTACTED CUSTOMER IN FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 176, 153 AND 139MG/DL. THE CUSTOMER DID NOT KNOW HIS EXPECTED GLUCOSE RANGE. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED HE HAD TESTED THREE DIFFERENT TIMES ON THE METER AND THE RESULTS HAD VARIED FROM 139 TO 153 TO 176MG/DL FASTING. CUSTOMER STATED HE DID NOT TRUST THE RESULTS AS HE WAS HAVING SYMPTOMS OF LOW BLOOD SUGAR (DIZZY AND LIGHTHEADED) AT THE TIME. CUSTOMER STATED HE WENT TO ER DUE TO THE SYMPTOMS. CUSTOMER STATED HIS BLOOD GLUCOSE TEST RESULT AT THE HOSPITAL OVER 30 MINUTES AFTER TESTING AT HOME HAD BEEN 122MG/DL FASTING. CUSTOMER STATED HE WAS NOT TREATED OR ADMITTED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 211 MG/DL AND 241MG/DL USING TRUE METRIX METER; CUSTOMER WAS NOT SATISFIED WITH THE RESULTS OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURERS EXPIRATION DATE IS 08/27/2021 AND OPEN VIAL DATE IS (B)(6) 2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503022 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, RLN TMX 100CTMG/DL MW4143S 00021292012236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention