BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION TMA

    MDR report key: 8351046 · Received February 19, 2019

    Report

    Report Number
    1000113657-2019-00139
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    January 25, 2019
    Report Date
    February 19, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007720
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). RETURNED METER AND RETURNED TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20-USER'S TEST STRIP HAD POOR STORAGE (KITCHEN). TEST STRIP UDI# (B)(4). NOTE: MANUFACTURER CONTACTED DISTRIBUTOR ON 2/4/2019 IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; REPRESENTATIVE STATED THAT CUSTOMER RECEIVED THE REPLACEMENT PRODUCT HOWEVER CUSTOMER IIS NOT AVAILABLE ET THE TIME, NO SYMPTOMS OR MEDICAL ATTENTION REPORTED SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CALL WAS TRANSFERRED FROM (B)(6) REPRESENTATIVE. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM FASTING RESULTS OBTAINED OF 180, 193, 179, 187 AND 200 MG/DL. CUSTOMER IS ALSO CONCERNED WITH TEST RESULTS FROM FASTING METER TO METER COMPARISON OF 200 MG/DL USING RELION TRUEMETRIX AIR AND 100 MG/DL USING ANOTHER DEVICE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. DAUGHTER STATED THAT ON (B)(6) 2019 CUSTOMER TESTED USING THE RELION TRUEMETRIX AIR METER AND OBTAINED A RESULT OF 200 MG/DL FASTING. DAUGHTER HAD TAKEN CUSTOMER TO THE ER WHERE THEY PERFORMED A BLOOD GLUCOSE TEST ON THE CUSTOMER AND OBTAINED A RESULT OF 100 MG/DL FASTING. DAUGHTER STATED THE TESTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. NO TREATMENT OR DIAGNOSIS WAS GIVEN; CUSTOMER WAS TOLD HER BLOOD GLUCOSE WAS NORMAL AND SHE WAS DISCHARGED. DURING THE CALL ON (B)(6) 2019, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/30/2020 AND OPEN VIAL DATE IS LAST MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143808 RELION TMA BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. RELION TMA MV3034 00021292007720

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR