BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11608870 · Received April 2, 2021

    Report

    Report Number
    1000113657-2021-00224
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    March 6, 2021
    Report Date
    April 2, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO RISK OF SWALLOWING OF FOREIGN OBJECTS THAT ARE NOT INTENDED TO BE IN THE HUMAN BODY (SUCH AS TEST STRIPS). NOTE: MANUFACTURER ATTEMPTED TO CONTACT CUSTOMER IN FOLLOW-UP CALL ON 03/08/2021 - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AND E-MAIL REPLY WAS SENT ADVISING CUSTOMER TO SEEK MEDICAL ATTENTION OR CONTACT THEIR DOCTOR. CUSTOMER HAD REPLIED VIA E-MAIL ON (B)(6) 2021 STATING HE HAD EXPERIENCED NO SYMPTOMS AS A RESULT OF SWALLOWING THE TEST STRIP AND DECLINED TO SEEK MEDICAL ATTENTION. MANUFACTURER ATTEMPTED TO CONTACT CUSTOMER IN FOLLOW-UP CALLS ON 03/09/2021 AND 03/16/2021 - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT VIA E-MAIL ON SATURDAY, (B)(6) 2021 THAT HE HAD SWALLOWED ONE TEST STRIP. CUSTOMER HAD INCLUDED HIS CONTACT NUMBER. NO FURTHER INFORMATION, INCLUDING PRODUCT INFORMATION, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505267 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other