BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2030659 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00623
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 20, 2011
    Report Date
    March 6, 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
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED SHE DOES NOT THINK SHE IS GETTING INSULIN FROM THE INFUSION DEVICE. PT STATED THE INFUSION DEVICE IS SUCKING THE INSULIN BACK INTO THE INFUSION TUBING INSTEAD OF DELIVERING IT. PT REPORTED WHEN SHE PRIMES THE INFUSION TUBING SHE WILL GET IT PRIMED BUT WHEN THE PRIME STOPS, THE INSULIN WILL GET SUCKED BACK INTO THE INFUSION TUBING. PT STATED IF SHE PROGRAMS A BOLUS OF 4.0 UNITS OF INSULIN SHE WILL ONLY GET 0.5 UNITS OF INSULIN. PT REPORTED THIS ISSUE HAS BEEN OCCURRING FOR 2 WEEKS. PT STATED EVERY TIME SHE GIVES A BOLUS SHE HAS TO GIVE MORE THAN SHE NORMALLY WOULD BECAUSE THE INFUSION DEVICE WILL SUCK THE INSULIN BACK INTO THE INFUSION TUBING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR INSULIN| INSULIN INFUSION SET