BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11643961 · Received April 9, 2021

    Report

    Report Number
    1000113657-2021-00238
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 9, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING THE DOCTOR DUE TO THE HIGH BLOOD GLUCOSE TEST RESULTS. METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. REPORTED DEFECT NOT REPRODUCED. NO DEFECT FOUND. MOST LIKELY UNDERLINE ROOT CAUSE: MLC-020 USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 23-MAR-2021 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED 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 NON-FASTING METER TO METER COMPARISON OF 132 MG/DL USING TRUEMETRIX METER AND 88 MG/DL USING ANOTHER DEVICE AND FROM NON-FASTING RESULTS OBTAINED OF 111 AND 132 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 -80 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT SHE HAD CONTACTED HER DOCTOR DUE TO THE RESULTS OBTAINED AND THAT DOCTOR HAD ADVISED HER TO CALL. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). 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: (B)(6). CUSTOMER IS CONCERNED THAT METER IS READING HIGH. CUSTOMER IS COMPARING METER TO ANOTHER METER (BRAND NOT SPECIFIED). SAYS THAT SHE TESTED ON THE TRUE METRIX AND GOT A READING OF 132MG/DL NON-FASTING THEN TESTED ON THE OTHER METER AND GOT A RESULT OF 88MG/DL. ADVISED CUSTOMER OF METER VARIANCE AND METER TO METER COMPARISONS. FOLLOWED TROUBLESHOOTING STEPS WITH CUSTOMER. CUSTOMER IS STORING STRIPS IN THE KITCHEN. ADVISED CUSTOMER OF PROPER STORAGE. SENDING REPLACEMENT METER, STRIPS AND CONTROL SOLUTION FOR CUSTOMER SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539914 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX CVS 100CT 12/CASE MG/DL ZX4127S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other