BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11977979 · Received June 10, 2021

    Report

    Report Number
    1000113657-2021-00369
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 13, 2021
    Report Date
    July 6, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007829
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 06-JULY-2021: H10: EXPIRED TEST STRIPS WERE RETURNED FOR EVALUATION - UNABLE TO TEST. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ADDED MOST LIKELY UNDERLYING ROOT CAUSE: MLC-012: PRODUCT EXPIRED.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. INVESTIGATION IS PROCESS. NOTE: MANUFACTURER ATTEMPTED TO CONTACT CUSTOMER ON SEVERAL OCCASIONS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN -UNABLE TO ESTABLISH CONTACT WITH CUSTOMER.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER DOES NOT KNOW HIS BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS AT TIME OF THE CALL. WIFE STATED THE DAY PRIOR CUSTOMER HAD NOT BEEN FEELING WELL AND HAD BEEN HAVING AN ISSUE WITH HIS VISION. CUSTOMER HAD GONE TO THE EMERGENCY ROOM; CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE EMERGENCY ROOM WAS 420MG/DL (FASTING/NON-FASTING WAS NOT DISCLOSED). CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA. CUSTOMER ALSO HAD A SKIN RASH THAT WAS POSSIBLY INFECTED. CUSTOMER WAS TREATED WITH INSULIN, IV FLUIDS AND METFORMIN. UPON DISCHARGE CUSTOMER HAD BEEN ADVISED TO FOLLOW-UP WITH HIS DOCTOR. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. CUSTOMER STATED THE PRODUCT IS STORED IN HER PURSE; TEST STRIPS ARE EXPIRED - THE MANUFACTURER¿S EXPIRATION DATE IS 04/30/2019. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873537 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 25CT24/CS MG/DL #383237 MU2665 00021292007829

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization