BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION SK

    MDR report key: 7446351 · Received April 20, 2018

    Report

    Report Number
    1000113657-2018-00453
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 27, 2018
    Report Date
    April 20, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIP VIAL RETURNED EMPTY - UNABLE TO TEST. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OF 211, 238 AND 309 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). THE CUSTOMER SAY HE IS GETTING HIGH RESULTS FROM THE METER AND HE TAKES HIS BLOOD TEST FASTING. THE CUSTOMER SAY HIS LAST A1C WAS (B)(6) BUT IT WAS NORMAL. HE CANNOT REMEMBER THE NUMBER. HE SAID SOME OF THE BLOOD WAS RESULT VERY HIGH AND HE WAS FASTING. CUSTOMER IS FEELING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289506 RELION SK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. RELION SK SU5192

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR