BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1853412 · Received September 27, 2010

    Report

    Report Number
    2183996-2010-02003
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 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
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED HER INSULIN CARTRIDGE LEAKED. PT STATED, THERE WAS A SMALL AMOUNT OF INSULIN IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. PT REPORTED, SHE WAS ABLE TO TAKE A NAPKIN AND WIPE OUT THE DAMP CONDENSATION. PT STATED, SHE DIDN'T KNOW WHERE IT LEAKED OUT FROM BUT THAT IT CAME FROM THE INSULIN CARTRIDGE. PT REPORTED, THERE WAS NO DAMAGE TO THE INSULIN CARTRIDGE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INSULIN CARTRIDGE 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 55 YR INSULIN INFUSION PUMP| INSULIN