BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2191270 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02094
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 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
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THERE WAS MOISTURE IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THIS WAS NOTICED DURING THE CARTRIDGE CHANGE PROCEDURE. SHE DOES HEAR AN AUDIBLE CLICK WHEN THE INFUSION TUBING IS CONNECTED TO THE HEADSET. THERE WAS NO VISIBLE DAMAGE TO THE CARTRIDGE. PT SUCCESSFULLY COMPLETED A CARTRIDGE CHANGE, PRIMED THE INFUSION SET, AND RESUMED NORMAL OPERATION DURING THE TROUBLESHOOTING CALL. CARTRIDGE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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 CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR INSULIN| INSULIN INFUSION SET| INSULIN INFUSION DEVICE