BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 12477570 · Received September 15, 2021

    Report

    Report Number
    1000113657-2021-00560
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    September 26, 2019
    Report Date
    September 16, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTIONS AS OF 16-SEPT- 2021: B3:THE TEST STRIPS ARE EXPIRED: 04/22/2018 CHANGED TO: THE TEST STRIPS ARE EXPIRED: 04/30/2018.

    Description of Event or Problem · 0

    THE TEST STRIPS ARE EXPIRED: 04/30/2018.

    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 AND TEST STRIPS WERE RETURNED. NO INVESTIGATION REQUIRED: TEST STRIPS ARE EXPIRED AND 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

    CUSTOMER CALLED IN STATES THAT SHE CANNOT OBTAIN THE PRODUCTS FOR HER METER. CUSTOMER IS NOT ALLEGING PRODUCT DEFECT. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION WITH USE OF PRODUCT WAS NOT REPORTED. CUSTOMER WAS UPGRADE TRUE METRIX PRODUCT LINE. THE TEST STRIPS ARE EXPIRED: 04/22/2018. CUSTOMER TEST STRIPS HAVE BEEN AFFECTED BY THE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376367 TRUERESULT SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC KIT, TRUERESULT NOT FORRETAIL SALE PS2301

    Patients

    Seq Age Sex Outcome Treatment
    1