BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION SK

    MDR report key: 7446622 · Received April 20, 2018

    Report

    Report Number
    1000113657-2018-00456
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 28, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. NO REPLACEMENT PRODUCT NEEDED AT THIS TIME. PRODUCT IS WORKING AS DESIGNED. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-18- USER HAS HIGH GLUCOSE VALUE NOTE: A CALL BACK WAS RECEIVED ON (B)(6) 2018; THE CALLER STATES THE CUSTOMER WAS GETTING THE HI BECAUSE OF HIS CHEMO MEDICATION AND IT IS NORMAL FOR IT TO CAUSE HIS SUGAR TO BE HIGH. THE CUSTOMER NO LONGER HAS THE METER AS IT WAS A DISPOSABLE METER. IT WAS ADVISED NOT TO CALL THE NUMBER BACK AND TO TAKE HIM OFF THE CALL LIST. UNABLE TO GET ANY MORE INFORMATION.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. DISTRIBUTOR EMAILED ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. 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 UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. PER INITIAL EMAIL:CUSTOMER IS STATING THAT SHE RECEIVED AN E3 ON HER ALL-IN-ONE. I WENT OVER SOME TROUBLESHOOTING STEPS, FIRST WE INSERTED A TEST STRIP INTO THE METER AND WAITED FOR THE FLASHING APPLY BLOOD SYMBOL. NEXT LANCE FINGER PALM FACING UPWARD AND BRING STRIP AT A DOWNWARD ANGLE TO BLOOD DROP WITHOUT TOUCHING THE FINGERTIP. I STAYED ON THE LINE WHILE PATIENT PERFORMED TEST AND RECEIVED A READING OF HI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289215 RELION SK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. RELION SK SU5192

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR