BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8925650 · Received August 23, 2019

    Report

    Report Number
    1000113657-2019-00847
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    July 30, 2019
    Report Date
    September 23, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007928
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE: T, CORRECTED DATA: F) INTERNAL REPORT#: (B)(4). METER WAS RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. TEST STRIPS WERE RETURNED FOR EVALUATION. UNABLE TO PERFORM EVALUATION DUE TO STRIPS PREVIOUSLY USED BY CUSTOMER. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-47: PCB CONTAMINATION. TEST STRIPS UDI: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THAT THE CUSTOMER'S CONDITION IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED CONDITION IMPROVED. 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 E-4 ERROR. THE E-4 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER WAS USING PROPER TESTING TECHNIQUE AND THE CORRECT TEST STRIPS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2020 AND OPEN VIAL DATE IS 07/30/2019. AT THE TIME OF THE CALL THE CUSTOMER FELT DIZZY. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING FOLLOW UP CALL, CUSTOMER STATED SHE CONTACTED HER DOCTOR DUE TO HER SYMPTOMS.

    Additional Manufacturer Narrative · 1

    (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-47: PCB CONTAMINATION. TEST STRIPS UDI: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THAT THE CUSTOMER'S CONDITION IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED CONDITION IMPROVED. 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 E-4 ERROR. THE E-4 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER WAS USING PROPER TESTING TECHNIQUE AND THE CORRECT TEST STRIPS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2020 AND OPEN VIAL DATE IS (B)(6) 2019. AT THE TIME OF THE CALL THE CUSTOMER FELT DIZZY. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING FOLLOW UP CALL, CUSTOMER STATED SHE CONTACTED HER DOCTOR DUE TO HER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720894 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MW3391S 00021292007928

    Patients

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