BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1983809 · Received January 20, 2011

    Report

    Report Number
    2183996-2010-02788
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 29, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THERE IS CONDENSATION IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. PATIENT STATED, SHE NOTICED THE LEAK BECAUSE, HER PAJAMAS WERE WET. PATIENT REPORTED, SHE DID NOT RECEIVE ANY ERROR MESSAGES. PATIENT STATED, SHE HAS NOT CHANGED THE INFUSION ADAPTER FOR A WHILE; IS NOT SURE HOW LONG IT HAS BEEN. HAD PATIENT REMOVE THE INSULIN CARTRIDGE. PATIENT REPORTED, THERE IS NO WATER OR INSULIN IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. PATIENT STATED, THE MOISTURE IS INSULIN AND IT IS INSIDE OF THE INSULIN CARTRIDGE. PATIENT REPORTED, THE INSULIN IS IN THE EMPTY/USED SIDE OF THE INSULIN CARTRIDGE ON THE INSIDE WHERE THE PLUNGER USED TO BE WHEN THE CARTRIDGE WAS FULL. PATIENT STATED, SHE CHANGED THE INSULIN CARTRIDGE AND THE INFUSION SET; WAS ABLE TO PLACE THE INFUSION DEVICE BACK IN THE RUN MODE. ATTEMPTS TO FOLLOW UP WITH PATIENT WERE UNSUCCESSFUL. THE PATIENT 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 EVALUATION.

    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 63 YR INSULIN| INSULIN INFUSION SET