BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1811126 · Received August 13, 2010

    Report

    Report Number
    2183996-2010-01583
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    June 5, 2010
    Report Date
    July 19, 2010
    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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE PISTON ROD ON THE INFUSION DEVICE WOULD NOT RETRACT. PT REPORTS THE PISTON ROD BEGAN TO "STICK" DURING THE LAST COUPLE OF CARTRIDGE CHANGES AND NOW PISTON ROD WILL NOT RETRACT AT ALL. PT IS USING CORRECT TYPE OF BATTERY. INFUSION DEVICE WAS BUMPED AGAINST A WOODEN DESK, BUT PT DOES NOT BELIEVE THERE WAS ENOUGH FORCE TO CAUSE THIS CONCERN. PT REPORTS PISTON ROD TYPICALLY MAKES A "LOUD GRINDING NOISE" DURING RETRACTION, BUT IT IS NOW MAKING A QUIET NOISE. PT CHANGED BATTERY AND ATTEMPTED TO RETRACT PISTON ROD AND THE SAME ISSUE OCCURRED. THE PISTON ROD MADE A QUIET NOISE AND DID NOT SPIN. NO ALERT OR ERROR MESSAGES WERE REPORTED. THERE HAS BEEN NO INSULIN INGRESS, AND INFUSION DEVICE HAS NOT BEEN DROPPED ON A HARD SURFACE WITHIN THE PAST 48 HOURS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 35 YR INFUSION SET| INSULIN