BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE2GO

    MDR report key: 9006523 · Received September 12, 2019

    Report

    Report Number
    1000113657-2019-00909
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    August 16, 2019
    Report Date
    October 16, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE: F, CORRECTED DATA: T) CORRECTED SECTIONS AS OF 01-OCT-2019: H11: MOST LIKELY UNDERLYING ROOT CAUSE CHANGED FROM MLC-22: CLIENT IS TESTING WITH EXPIRED TEST STRIPS TO MLC-12: PRODUCT EXPIRED. INTERNAL REPORT: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-12: PRODUCT EXPIRED. TEST STRIPS UDI: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN, UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE: F, CORRECTED DATA: T) CORRECTED SECTIONS AS OF 01-OCT-2019: H11: MOST LIKELY UNDERLYING ROOT CAUSE CHANGED FROM MLC-22: CLIENT IS TESTING WITH EXPIRED TEST STRIPS TO MLC-12: PRODUCT EXPIRED. INTERNAL REPORT: (B)(4). METER WAS RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-12: PRODUCT EXPIRED. TEST STRIPS UDI: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN, UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR LO DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75-80MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IT IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/17/2019 AND OPEN VIAL DATE IS 3/16/2019 (EXPIRED). THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. RESULT 1: LO FASTING, RESULT 2: LO FASTING, RESULT 3: LO FASTING, RESULT 4: LO FASTING, RESULT 5: 131MG/DL FASTING.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR LO DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75-80MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IT IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/17/2019 AND OPEN VIAL DATE IS 3/16/2019 (EXPIRED). THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. RESULT 1: LO FASTING, RESULT 2: LO FASTING, RESULT 3: LO FASTING, RESULT 4: LO FASTING, RESULT 5: 131MG/DL 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-22: CLIENT IS TESTING WITH EXPIRED TEST STRIPS. TEST STRIPS UDI: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LO DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75-80MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IT IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/17/2019 AND OPEN VIAL DATE IS 3/16/2019 (EXPIRED). THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802896 TRUE2GO BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUE2GO PT2692

    Patients

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