BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION SK

    MDR report key: 6325837 · Received February 13, 2017

    Report

    Report Number
    1000113657-2017-00271
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    January 17, 2017
    Report Date
    February 13, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: STRIP ISSUE. NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL IN ORDER TO ENSURE THE CUSTOMER'S INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. (B)(6) REPORTER, SUSAN IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/17/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WASN'T REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(4). EMAIL SENT: (B)(6) 2017 4:45:01 PM: REPORTER (B)(6) CALLED ON BEHALF OF PATIENT (B)(6) STATING HE RECEIVED A HI AND THEN A E03 AND THEN AN E02 ON HIS ALL-IN-ONE METER. I INFORMED PATIENT E02 MEANT THE SAMPLE WAS NOT DETECTED AND THAT E03 MEANT THAT THE TEST STRIP WAS WRONG. 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 AND BRING STRIP TO BLOOD DROP WITHOUT TOUCHING THE FINGERTIP. I STAYED ON THE LINE WHILE PATIENT PERFORMED TEST AND RECEIVED A READING OF E2 AND THEN HE DID IT AGAIN AND GOT A HI. I ADVISED PATIENT TO GIVE US A CALL BACK LATER. A REPLACEMENT WAS ISSUED BY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108697 RELION SK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. RELION SK SS4834

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY