BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6208996 · Received December 28, 2016

    Report

    Report Number
    1000113657-2016-02099
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    December 3, 2016
    Report Date
    January 17, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00050428375105
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND RETURNED TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD POOR STORAGE (KITCHEN). TEST STRIP UDI# (B)(4).

    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. TEST STRIP UDI# (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 174, 171 AND 116 MG/DL. 174 AND 171 ARE NON-FASTING RESULTS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 60 - 90 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 NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/14/2017 AND OPEN VIAL DATE AT TIME OF CALL IS A MONTH AND A HALF. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: A 174MG/DL, (B)(6) 2016 02:01 PM, FASTING: NO. A 171MG/DL, (B)(6) 2016 02:00 PM, FASTING: NO. A 116MG/DL, (B)(6) 2016 12:16 PM, FASTING: YES. A 188MG/DL, (B)(6) 2016 01:10 AM, FASTING: YES. A 187MG/DL, (B)(6) 2016 01:10 AM, FASTING: YES. MEMORY CONCERNS: 174, 171, 188, 187MG/DL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 174, 171 AND 116 MG/DL. 174 AND 171 ARE NON-FASTING RESULTS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 60 - 90 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 NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/14/2017 AND OPEN VIAL DATE AT TIME OF CALL IS A MONTH AND A HALF. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 174MG/DL (B)(6) 2016 02:01 PM FASTING: NO; 171MG/DL (B)(6) 2016 02:00 PM FASTING: NO; 116MG/DL (B)(6) 2016 12:16 PM FASTING: YES; 188MG/DL (B)(6) 2016 01:10 AM FASTING: YES; 187MG/DL (B)(6) 2016 01:10 AM FASTING: YES. MEMORY CONCERNS: 174 171 188 187MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858241 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1666 00050428375105

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY