BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8628702 · Received May 21, 2019

    Report

    Report Number
    1000113657-2019-00544
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    April 29, 2019
    Report Date
    June 13, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007928
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # 01634679 METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20 USER'S TEST STRIP HAD POOR STORAGE. TEST STRIP UDI#: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE 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 AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 263, 203, 249, 190 AND 234 MG/DL. CUSTOMER WAS PERFORMING BACK TO BACK TESTING ON SAME HAND, DIFFERENT FINGERS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 120 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, 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 BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/28/2020 AND TEST STRIPS WERE OPENED ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 263 MG/DL, DATE: 4/29/2019, TIME: 8:22 AM FASTING; RESULT 2: 203 MG/DL, DATE: 4/29/2019, TIME: 8:20 AM FASTING. RESULT 3: 249 MG/DL DATE: 4/29/19 TIME: 8:19 AM FASTING RESULT 4: 190 MG/DL DATE: 4/29/19 TIME: 8:16 AM FASTING RESULT 5: 234 MG/DL DATE: 4/29/19 TIME: 8:15 AM FASTING.

    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-18- USER HAS HIGH GLUCOSE VALUE. TEST STRIP UDI#: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE 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 AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 263, 203, 249, 190 AND 234 MG/DL. CUSTOMER WAS PERFORMING BACK TO BACK TESTING ON SAME HAND, DIFFERENT FINGERS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 120 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, 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 BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/28/2020 AND TEST STRIPS WERE OPENED ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421027 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV3081S 00021292007928

    Patients

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