BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8972042 · Received September 6, 2019

    Report

    Report Number
    1000113657-2019-00885
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 12, 2019
    Report Date
    October 16, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007928
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # 01653245 METER WAS RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-62: USER HAD POOR TECHNIQUE TEST STRIPS UDI: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED REPLACEMENT PRODUCT RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 180, 188, 204, 165, 222, 197 AND 202MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 150 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 242 MG/DL AND 245 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/22/2020 AND TEST STRIPS WERE OPENED TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: 120 MG/DL DATE: (B)(6) 2019 TIME: 07:33PM FASTING RESULT 2: 171 MG/DL DATE: (B)(6) 2019 TIME: 10:33AM FASTING RESULT 3: 123 MG/DL DATE: (B)(6) 2019 TIME: 09:59AM FASTING RESULT 4: 83 MG/DL DATE: (B)(6) 2019 TIME: 09:12AM FASTING RESULT 5: 112 MG/DL DATE: (B)(6) 2019 TIME: 07:21AM FASTING.

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # (B)(4) METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-62: USER HAD POOR TECHNIQUE TEST STRIPS UDI: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED REPLACEMENT PRODUCT RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 180, 188, 204, 165, 222, 197 AND 202MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 150 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 242 MG/DL AND 245 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/22/2020 AND TEST STRIPS WERE OPENED TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765468 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MW3268S 00021292007928

    Patients

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