BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6158643 · Received December 9, 2016

    Report

    Report Number
    1000113657-2016-01990
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 29, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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: ENVIRONMENTAL TESTING CONDITIONS(CONTROL SOLUTION).

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). PRODUCT DOES NOT RETURN FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: ENVIRONMENTAL TESTING CONDITIONS(CONTROL SOLUTION).

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR LOW RESULTS WHEN TESTING WITH CONTROL TEST SOLUTION. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM CONTROL TEST RESULT OBTAINED OF 23 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 99 - 110 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 STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/17/2018 AND OPEN VIAL DATE IS 11/10/2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER HAD A DIFFICULT TIME READING DATES AND TIMES): (B)(6). MEMORY CONCERNS:23 MG/DL CONTROL TEST RESULT. WHEN TESTING WITH CONTROL SOLUTIONS, CUSTOMER OBTAINED A 23 MG/DL RESULT WITH A CONTROL LEVEL 3 ON TWO DIFFERENT OCCASIONS WHILE ON THE PHONE WITH ME. CUSTOMER HAD TESTED WITH CONTROL SOLUTION 2 AND OBTAINED 127 MG/DL, AND TESTED WITH CONTROL SOLUTION 1 AND ALSO OBTAINED A 23 MG/DL RESULT. CUSTOMER HAD A DIFFICULT TIME READING DATES AND TIMES FROM METER MEMORY. CUSTOMER SEEMED TO BE FOLLOWING INSTRUCTIONS AND CONTINUED TO OBTAIN A LOW READING WITH LEVEL 3 CONTROL SOLUTION.

    Description of Event or Problem · 1

    COSTUMER REPORTED COMPLAINT FOR LOW RESULTS WHEN TESTING WITH CONTROL TEST SOLUTION. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM CONTROL TEST RESULT OBTAINED OF 23 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 99 - 110 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 STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/17/2018 AND OPEN VIAL DATE IS 11/10/2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER HAD A DIFFICULT TIME READING DATES AND TIMES): THE 23MG/DL (B)(6) 2016 03:53 PM CONTROL, THE 144MG/DL (B)(6) 2016 03:45 PM FASTING:NO, THE 132MG/DL DATE:N/A TIME: N/A FASTING:NO, THE 137MG/DL DATE:N/A TIME: N/A FASTING:NO, THE 174MG DL DATE:N/A TIME: N/A FASTING:NO. MEMORY CONCERNS:23 MG/DL CONTROL TEST RESULT. WHEN TESTING WITH CONTROL SOLUTIONS, CUSTOMER OBTAINED A 23 MG/DL RESULT WITH A CONTROL LEVEL 3 ON TWO DIFFERENT OCCASIONS WHILE ON THE PHONE WITH ME. CUSTOMER HAD TESTED WITH CONTROL SOLUTION 2 AND OBTAINED 127 MG/DL, AND TESTED WITH CONTROL SOLUTION 1 AND ALSO OBTAINED A 23 MG/DL RESULT. CUSTOMER HAD A DIFFICULT TIME READING DATES AND TIMES FROM METER MEMORY. CUSTOMER SEEMED TO BE FOLLOWING INSTRUCTIONS AND CONTINUED TO OBTAIN A LOW READING WITH LEVEL 3 CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808016 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1964 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY