BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2172357 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01742
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 26, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HE ATTEMPTED TO RETURN THE PISTON ROD ON HIS INFUSION DEVICE THIS AFTERNOON AND COULDN'T GET THE PISTON ROD TO RETURN AND RECEIVED AN ERROR MESSAGE. PT STATED HE SWITCHED TO HIS BACKUP INFUSION DEVICE. PT CURRENTLY DOES NOT HAVE THE ALLEGED DEVICE WITH HIM. PT REPORTED THE INFUSION DEVICE WORKED FINE BUT A WHILE BACK HE TOOK OUT A CARTRIDGE AND IT SMELLED OF INSULIN. PT STATED HE SAW A COUPLE OF DROPS OF INSULIN IN THE CARTRIDGE COMPARTMENT. PT REPORTED IT WAS A VERY SMALL AMOUNT AND HE WAS ABLE TO DRY IT OUT. PT STATED HE FEELS THE INSULIN CARTRIDGE LEAKED. ON CALL BACK PT REPORTED HE COULD HEAR THE PISTON ROD MAKING A CLICKING, ABNORMAL NOISE WHEN RETRACTING THIS EVENING. PT STATED THE PISTON ROD GOT STUCK AND THEN CONTINUED TO RETRACT. PT REPORTED HE CAN HEAR A RATTLE; NOISE HIS BACKUP INFUSION DEVICE DOES NOT MAKE. PT STATED THERE IS NO SPINNING AND IT DOES NOT APPEAR TO BE CRACKED OR LOOSE. PT REPORTED THE NOISE OCCURS WHEN THE PISTON ROD IS RETRACTING. PT STATED WHEN HE ATTEMPTED TO RAISE THE PISTON ROD IT BEGAN TO MAKE ANOTHER ABNORMAL NOISE, A RATTLE, BUT DOES NOT APPEAR TO STICK. VERIFIED INSULIN SPILLED IN THE INFUSION DEVICE ABOUT A MONTH AGO. PT STATED IT WAS A SMALL AMOUNT AND HE WIPED IT OUT WITH A COTTON SWAB. PT REPORTED HE IS NOT CERTAIN HOW IT OCCURRED. 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 PRODUCT FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR INSULIN INFUSION PUMP| INSULIN| INSULIN INFUSION SET