BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION SK

    MDR report key: 6760137 · Received August 2, 2017

    Report

    Report Number
    1000113657-2017-01503
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 10, 2017
    Report Date
    August 2, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20-USER'S TEST STRIP HAD POOR STORAGE (KITCHEN).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH ALL RESULTS OBTAINED: 164, 121, 154, 208 AND 91 MG/DL. THE CUSTOMER REPORTED A FASTING METER TO METER COMPARISON TEST THAT PRODUCED RESULT OF 121 MG/DL USING THE RELION SK METER AND A RESULT OF 164 MG/DL USING DR.'S DEVICE (CUSTOMER HAD ALSO RECEIVED A RESULT OF 164 MG/DL USING RELION SK METER THAT IS IN THE METER MEMORY). THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 115 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, 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 08/21/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER IS CONCERNED WITH ALL FIVE RESULTS IN THE MEMORY): (B)(6). MEMORY CONCERNS:CUSTOMER CONCERNED WITH ALL THE 5 RESULTS PROVIDED INT HEMETER'S MEMORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540772 RELION SK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. RELION SK SU5092

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR