BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2800130 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01578
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    October 6, 2012
    Report Date
    October 6, 2012
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT REPORTED MOISTURE IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. HE IS UNSURE WHERE THE LEAK ORIGINATED BUT STATED THERE APPEARS TO BE MOISTURE AROUND THE PLUNGER OF THE INSULIN CARTRIDGE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INSULIN CARTRIDGE, ADAPTER, AND INFUSION SET WERE REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN