BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2396678 · Received November 23, 2011

    Report

    Report Number
    2183996-2011-02871
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    October 25, 2011
    Report Date
    November 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT AND HER HUSBAND REPORTED SHE HAS BEEN HAVING SOME ELEVATED BLOOD GLUCOSE LEVELS AT TIMES AND SOME LOW BLOOD GLUCOSE LEVELS AT OTHERS. PT STATED HER BLOOD GLUCOSE LEVEL HAS BEEN GOING FROM A LOWER NUMBER LIKE 54-71 MG/DL AND THEN SHE WILL EAT TO BRING IT BACK UP. PT REPORTED THIS HAS BEEN OCCURRING EVERY ONCE IN A WHILE IN THE MIDDLE OF THE NIGHT AROUND 2 AM. PT'S HUSBAND STATED SHE WOULD BE ABLE TO TREAT HERSELF IF HE WASN'T THERE. HUSBAND REPORTED SHE EATS A (B)(6) OR USES GLUCOSE SPRAY TO BRING HER BLOOD GLUCOSE LEVEL BACK UP. PT STATED HER BLOOD GLUCOSE LEVEL WILL THEN COME UP TO THE 230-312 MG/DL RANGE AND THEN SHE CAN'T GET IT TO COME DOWN. HUSBAND REPORTED HE IS AFRAID THAT THE INFUSION DEVICE IS NOT DELIVERING THE INSULIN TO HER CORRECTLY. HUSBAND STATED THE PT WILL BOLUS AND IF IT DOESN'T COME DOWN, SHE WILL CHANGE THE INFUSION SITE AND IF THAT DOESN'T BRING IT BACK DOWN SHE WILL THEN USE INJECTIONS AND DRINK WATER UNTIL IT COMES BACK DOWN TO NORMAL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 90-140 MG/DL. PT REPORTED THERE HAVE BEEN NO ALARMS OR ERROR MESSAGES TO LET THEM KNOW THERE IS AN ISSUE. PT HAS BEEN HAVING THIS ISSUE WITH MORE THAN ONE VIAL OF INSULIN. PT STATED SHE HAS BEEN UNDER A LITTLE STRESS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR INSULIN| INSULIN INFUSION PUMP AND RELATED ACCESSORIES