BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1021837 · Received March 28, 2008

    Report

    Report Number
    2183996-2008-00418
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 8, 2008
    Report Date
    March 8, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THERE IS CONDENSATION IN THE CARTRIDGE COMPARTMENT OF HIS INSULIN INFUSION DEVICE. HE STATED HE USED A COTTON SWAB TO REMOVE THE EXCESS MOISTURE. THE PT WAS SENT COURTESY CARTRIDGES. ON FOLLOW UP, THE PT STATED THAT EVERYTHING WAS FINE. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE FPA DISETRONIC MEDICAL SYSTEMS NA 7I103PC

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP| INSULIN INFUSION SET