BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2112199 · Received April 29, 2011

    Report

    Report Number
    2183996-2011-01286
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 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
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THAT THE CARTRIDGE LEAKED INSULIN INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THERE WERE DRIED INSULIN CRYSTALS IN THE CARTRIDGE COMPARTMENT AND ENOUGH INSULIN TO POUR OUT. THE INSULIN LEAKED FROM THE PLUNGER OF THE CARTRIDGE. THE PLUNGER WAS NOT STUCK ON THE PISTON ROD, AND THE CARTRIDGE WAS REMOVED PROPERLY. THE INFUSION DEVICE, CARTRIDGE, AND ADAPTER WERE REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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 26 YR INSULIN INFUSION DEVICE| INSULIN| INSULIN INFUSION SET