BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1120243 · Received August 14, 2008

    Report

    Report Number
    2183996-2008-01219
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 27, 2008
    Report Date
    July 27, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    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

    IN 2008, THE PATIENT REPORTED THAT THE PLUNGER CAME OUT OF HIS INSULIN CARTRIDGE WHEN IT WAS INSERTED INTO THE INFUSION DEVICE CAUSING INSULIN TO SPILL INTO THE CARTRIDGE COMPARTMENT. HE STATED THAT HE WAS AWAY FROM HOME, AND DID NOT HAVE ANOTHER INSULIN CARTRIDGE WITH HIM. HE SWITCHED TO INJECTION THERAPY. UPON FOLLOW UP THE FOLLOWING MONTH, THE PT STATED THAT HE DRIED THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE WHEN HE RETURNED HOME, AND HAS BEEN USING IT SINCE THAT TIME. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR INSULIN INFUSION PUMP| INSULIN| INSULIN INFUSION SET