BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6392999 · Received March 9, 2017

    Report

    Report Number
    1000113657-2017-00462
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    February 14, 2017
    Report Date
    March 29, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006051
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD POOR STORAGE (PANTRY NEAR THE DRYER). (B)(4).

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD POOR STORAGE (PANTRY NEAR THE DRYER). TEST STRIP (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 262 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 - 103 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE PANTRY NEAR THE DRYER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2018 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: 200 262 113 106MG/DL. CUSTOMER IS CALLING FOR HER DAUGHTER. CUSTOMER IS CONCERNED THAT HER DAUGHTER'S METER IS READING TOO HIGH. I ASKED CUSTOMER IF SHE IS EXPERIENCING SYMPTOMS OF HIGH/LOW BLOOD SUGAR, CUSTOMER STATED SHE IS NOT AND THAT SHE IS FEELING WELL. CUSTOMER STATED HER NORMAL BLOOD SUGAR RANGE OF READING IS BETWEEN: 85-103MG/DL FASTING. I ASKED IF THERE WAS ANY RECENT CHANGES IN MEDICATION. CUSTOMER STATES THAT HER DAUGHTER FINISHED A STEROID PACK A MONTH AGO AND WAS EATING COUGH DROPS.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 262 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 - 103 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE PANTRY NEAR THE DRYER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2018 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CALLING FOR HER DAUGHTER. CUSTOMER IS CONCERNED THAT HER DAUGHTER'S METER IS READING TOO HIGH. I ASKED CUSTOMER IF SHE IS EXPERIENCING SYMPTOMS OF HIGH/LOW BLOOD SUGAR, CUSTOMER STATED SHE IS NOT AND THAT SHE IS FEELING WELL. CUSTOMER STATED HER NORMAL BLOOD SUGAR RANGE OF READING IS BETWEEN: 85-103 MG/DL FASTING. I ASKED IF THERE WAS ANY RECENT CHANGES IN MEDICATION. CUSTOMER STATES THAT HER DAUGHTER FINISHED A STEROID PACK A MONTH AGO AND WAS EATING COUGH DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175203 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT2057 00021292006051

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY