BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6141362 · Received December 2, 2016

    Report

    Report Number
    1000113657-2016-01945
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 9, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (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).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (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).

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 TO 125MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION,CUSTOMER STORES THE PRODUCT IN THE KITCHEN. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULT. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/22/2017 AND OPEN VIAL DATE,CUSTOMER IS . THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): 1:151MG/DL (B)(6) 2016 04:18 PM FASTING: YES 2:193MG/DL (B)(6) 2016 04:17 PM FASTING: YES 3:191MG/DL (B)(6) 2016 04:16 PM FASTING: YES 4:168MG/DL (B)(6) 2016 04:15 PM FASTING: YES 5:87MG/DL (B)(6) 2016 07:01 AM FASTING: YES. MEMORY CONCERNS:HIGH RESULTS.

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 TO 125MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION, CUSTOMER STORES THE PRODUCT IN THE KITCHEN. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULT. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/22/2017 AND OPEN VIAL DATE,CUSTOMER IS . THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): 151MG/DL (B)(6) 2016 04:18 PM FASTING: YES; 193MG/DL (B)(6) 2016 04:17 PM FASTING: YES; 191MG/DL (B)(6) 2016 04:16 PM FASTING: YES; 168MG/DL (B)(6) 2016 04:15 PM FASTING: YES; 87MG/DL (B)(6) 2016 07:01 AM FASTING: YES. MEMORY CONCERNS:HIGH RESULTS.

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 TO 125MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION,CUSTOMER STORES THE PRODUCT IN THE KITCHEN. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULT. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/22/2017 AND OPEN VIAL DATE,CUSTOMER IS . THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). MEMORY CONCERNS:HIGH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791403 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1489 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY