BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 8582693 · Received May 6, 2019

    Report

    Report Number
    1000113657-2019-00449
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 20, 2020
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007638
    PMA / PMN Number
    K032657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) SECTIONS WITH ADDITIONAL INFORMATION AS OF 15-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. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-57- USER HAD AN INACCURATE REFERENCE: ALTERNATE METER: THE END USER IS COMPARING RESULTS OBTAINED FROM ONE OF TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM ANOTHER TRIVIDIA'S BGM SYSTEM. TEST STRIP UDI#:(01)00021292008642(17)210530(10)RV5320. NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE CUSTOMER SYMPTOMS IMPROVED AND REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-200MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY, SWEATY AND DISORIENTED THREE DAYS AGO. MEDICAL ATTENTION WAS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS, CUSTOMER SAYS SHE THEN CALLED THE PARAMEDICS AND WENT TO THE HOSPITAL; WHILE AT THE HOSPITAL SHE TESTED HER GLUCOSE LEVELS AT THE SAME TIME OF BEING TESTED BY HOSPITAL STAFF AND HER METER READ 320MG/DL NON-FASTING WHILE THE HOSPITALS METER READ 170MG/DL NON-FASTING. CUSTOMER STATES SHE WAS DIAGNOSED WITH HYPOGLYCEMIA. CUSTOMER SAYS SHE WAS ONLY GIVEN FOOD TO EAT AND FLUIDS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/30/2021 AND OPEN VIAL DATE IS 4/7/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. RESULT 1: 320MG/DL DATE:4/7/2019 TIME: 11:26PM UNKNOWN; RESULT 2: 264MG/DL DATE:4/7/2019 TIME: 6:14PM UNKNOWN; RESULT 3: 93MG/DL DATE:4/5/2019 TIME: 9:53AM UNKNOWN; RESULT 4: HI DATE:4/4/2019 TIME: 10:44PM UNKNOWN; RESULT 5: 561MG/DL DATE:4/4/2019 TIME: 10:24PM UNKNOWN.

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT: # (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-57- USER HAD AN INACCURATE REFERENCE: ALTERNATE METER: THE END USER IS COMPARING RESULTS OBTAINED FROM ONE OF TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM ANOTHER TRIVIDIA'S BGM SYSTEM. TEST STRIP UDI#: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE CUSTOMER SYMPTOMS IMPROVED AND REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-200MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY, SWEATY AND DISORIENTED THREE DAYS AGO. MEDICAL ATTENTION WAS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS, CUSTOMER SAYS SHE THEN CALLED THE PARAMEDICS AND WENT TO THE HOSPITAL; WHILE AT THE HOSPITAL SHE TESTED HER GLUCOSE LEVELS AT THE SAME TIME OF BEING TESTED BY HOSPITAL STAFF AND HER METER READ 320MG/DL NON-FASTING WHILE THE HOSPITALS METER READ 170MG/DL NON-FASTING. CUSTOMER STATES SHE WAS DIAGNOSED WITH HYPOGLYCEMIA. CUSTOMER SAYS SHE WAS ONLY GIVEN FOOD TO EAT AND FLUIDS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/30/2021 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376723 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RV5320 00021292007638

    Patients

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