BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 12489119 · Received September 17, 2021

    Report

    Report Number
    1000113657-2021-00583
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    December 19, 2019
    Report Date
    September 17, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). PRODUCT PROBLEM BEING SUBMITTED DUE TO TEST STRIPS BEING PART OF RECALL: 1052693-06/13/16-001-R STRIP . METER WAS RETURNED. TEST STRIPS WERE NOT RETURNED TO MANUFACTURER. METER WAS RETURNED, NO INVESTIGATION REQUIRED: CUSTOMER DID NOT ALLEGE PRODUCT DEFECT. ROOT CAUSE: RC-074-MANUFACTURER-PROCESSING ERROR. MANUFACTURER ACKNOWLEDGES THE LATENESS OF THIS REPORT AND INITIATED THE NECESSARY CORRECTIVE ACTION. MANUFACTURER CORRECTIVE ACTION NUMBER: (B)(4).

    Description of Event or Problem · 1

    INFORMED CUSTOMER THAT TRUE RESULT/TRUE2GO (PQQ) SYSTEMS HAVE BEEN DISCONTINUED. UPGRADED CUSTOMER¿S DISCONTINUED PRODUCTS TO TRUE METRIX SELF-MONITORING SYSTEM: METER/STRIPS/CONTROL SOLUTION. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION WITH USE OF PRODUCT WAS NOT REPORTED. THE TEST STRIPS ARE EXPIRED: 04/23/2018. CUSTOMER TEST STRIPS HAVE BEEN AFFECTED BY THE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383638 TRUERESULT SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, CVS 100CTTRUETEST PS2293

    Patients

    Seq Age Sex Outcome Treatment
    1