BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 7855680 · Received September 7, 2018

    Report

    Report Number
    1000113657-2018-00934
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    August 15, 2018
    Report Date
    May 7, 2020
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292001391
    PMA / PMN Number
    K032657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) SECTIONS WITH ADDITIONAL INFORMATION AS OF 07-MAY-2020: H6: UPDATED FDA'S METHOD, RESULT, AND CONCLUSION 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 AND PASSED. INTERNAL REPORT # (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. CUSTOMER DECLINED REPLACEMENT PRODUCT AT THIS TIME. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-18- USER HAS HIGH GLUCOSE VALUE TEST STRIP UDI# (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER ON (B)(6) 2018 IN A FOLLOW-UP CALL TO ENSURE THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL; SON STATES HIS FATHER ENDED UP IN THE HOSPITAL WITH HYPERGLYCEMIA. CUSTOMER WAS ADMITTED ON (B)(6) 2018 WITH A BLOOD GLUCOSE OF 600MG/DL. CUSTOMER CURRENTLY IN HOSPITAL. MANUFACTURER CONTACTED CUSTOMER ON (B)(6) 2018 IN A FOLLOW-UP CALL: CUSTOMER'S CONDITION HAS IMPROVED. SON STATES HE'S STABLE BUT STILL IN THE HOSPITAL WITH GLUCOSE FLUCTUATING BECAUSE OF STEROIDS CUSTOMER IS TAKING DUE TO CANCER. MANUFACTURER CONTACTED CUSTOMER ON(B)(6) 2018 IN A FOLLOW-UP CALL: CUSTOMER HAVE IMPROVED. CUSTOMER WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. CUSTOMER IS NOW ON INSULIN. SON STATES ONCOLOGIST TOOK CUSTOMER OFF STEROIDS THAT CAUSE GLUCOSE TO SPIKE OUT OF CONTROL.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2020 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. VERIFIED CUSTOMER WAS USING INCORRECT CODE CHIP 4964. OFFERED TO REPLACE SYSTEM FOR SON AND HE REFUSES AND STATES HE RATHER GO AND BUY A NEW VIAL BECAUSE HE DOES NOT WANT TO WAIT FOR A REPLACEMENT. SON STATES FATHER WAS IN THE HOSPITAL YESTERDAY DUE TO A READING OF 550MG/DL NON-FASTING. SON STATES METFORMIN WAS TAKEN 3-4 HOURS AGO, AND HE WANTS TO MAKE SURE HIS DAD'S GLUCOSE HAS COME DOWN. CUSTOMER DENIES THE NEED FOR MEDICAL ATTENTION AT THE TIME OF CALL AND DENIES SIGNS AND SYMPTOMS OF HYPERGLYCEMIA AT THE TIME OF CALL. SON DECLINES REPLACEMENT AT THIS TIME DUE TO THEM HAVING THE WRONG CODE CHIP INSERTED INTO THE METER. SON DOES NOT WANT TO PROCEED ANY FURTHER WITH PROVIDING MORE INFORMATION AT THIS TIME. SON STATES HE RATHER GO PURCHASE A NEW VIAL OF STRIPS TO TEST HIS DAD SINCE HAS WAS JUST RELEASED FROM THE HOSPITAL ON YESTERDAY.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. CUSTOMER DECLINED REPLACEMENT PRODUCT AT THIS TIME. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-18- USER HAS HIGH GLUCOSE VALUE TEST STRIP UDI# (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER ON (B)(4) 2018 IN A FOLLOW-UP CALL TO ENSURE THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL; SON STATES HIS FATHER ENDED UP IN THE HOSPITAL WITH HYPERGLYCEMIA. CUSTOMER WAS ADMITTED ON (B)(6) 2018 WITH A BLOOD GLUCOSE OF 600MG/DL. CUSTOMER CURRENTLY IN HOSPITAL. MANUFACTURER CONTACTED CUSTOMER ON (B)(4) 2018 IN A FOLLOW-UP CALL: CUSTOMER'S CONDITION HAS IMPROVED. SON STATES HE'S STABLE BUT STILL IN THE HOSPITAL WITH GLUCOSE FLUCTUATING BECAUSE OF STEROIDS CUSTOMER IS TAKING DUE TO CANCER. MANUFACTURER CONTACTED CUSTOMER ON (B)(4) 2018 IN A FOLLOW-UP CALL: CUSTOMER HAVE IMPROVED. CUSTOMER WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. CUSTOMER IS NOW ON INSULIN. SON STATES ONCOLOGIST TOOK CUSTOMER OFF STEROIDS THAT CAUSE GLUCOSE TO SPIKE OUT OF CONTROL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2020 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. VERIFIED CUSTOMER WAS USING INCORRECT CODE CHIP 4964. OFFERED TO REPLACE SYSTEM FOR SON AND HE REFUSES AND STATES HE RATHER GO AND BUY A NEW VIAL BECAUSE HE DOES NOT WANT TO WAIT FOR A REPLACEMENT. SON STATES FATHER WAS IN THE HOSPITAL YESTERDAY DUE TO A READING OF 550MG/DL NON-FASTING. SON STATES METFORMIN WAS TAKEN 3-4 HOURS AGO, AND HE WANTS TO MAKE SURE HIS DAD'S GLUCOSE HAS COME DOWN. CUSTOMER DENIES THE NEED FOR MEDICAL ATTENTION AT THE TIME OF CALL AND DENIES SIGNS AND SYMPTOMS OF HYPERGLYCEMIA AT THE TIME OF CALL. SON DECLINES REPLACEMENT AT THIS TIME DUE TO THEM HAVING THE WRONG CODE CHIP INSERTED INTO THE METER. SON DOES NOT WANT TO PROCEED ANY FURTHER WITH PROVIDING MORE INFORMATION AT THIS TIME. SON STATES HE RATHER GO PURCHASE A NEW VIAL OF STRIPS TO TEST HIS DAD SINCE HAS WAS JUST RELEASED FROM THE HOSPITAL ON YESTERDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696311 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RV5224 00021292001391

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization SECOND THERAPY| SECOND THERAPY