BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6149274 · Received December 6, 2016

    Report

    Report Number
    1000113657-2016-01960
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 19, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007041
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:USER'S TEST STRIPS HAD A POOR STORAGE(KITCHEN). (B)(4).

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). PRODUCT DOES NOT RETURN FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:USER'S TEST STRIPS HAD A POOR STORAGE(KITCHEN). NOTE: TEST STRIP-(B)(4).

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 181, 177 AND 186 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-130 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. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 195 AND 209 MG/DL. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION,CUSTOMER STORES THE PRODUCT IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/16/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(4). MEMORY CONCERNS: ALL RESULTS FROM METER MEMORY. CUSTOMER HAS NOT HAD ANY RECENT CHANGES IN HER DIET, EXERCISE, OR MEDICATIONS. CUSTOMER INFORMED OF PROPER SUPPLY STORAGE.

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 181, 177 AND 186 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-130 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. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 195 AND 209 MG/DL. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION,CUSTOMER STORES THE PRODUCT IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/16/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: ALL RESULTS FROM METER MEMORY. CUSTOMER HAS NOT HAD ANY RECENT CHANGES IN HER DIET, EXERCISE, OR MEDICATIONS. CUSTOMER INFORMED OF PROPER SUPPLY STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800606 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1850 00021292007041

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY