BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1243181 · Received November 7, 2008

    Report

    Report Number
    2183996-2008-01684
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 26, 2008
    Report Date
    October 26, 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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2008, THE PATIENT REPORTED THAT SHE NOTICED CONDENSATION IN THE CARTRIDGE COMPARTMENT OF HER INFUSION DEVICE WHILE CHANGING THE INSULIN CARTRIDGE. SHE STATED THAT SHE DRIED THE CARTRIDGE COMPARTMENT WITH A COTTON SWAB. SHE STATED THAT SHE DOES NOT CONNECT THE INSULIN CARTRIDGE, ADAPTER, AND INFUSION TUBING PRIOR TO INSERTION INTO THE INFUSION DEVICE. SHE WAS EDUCATED ON THE PROPER PROCEDURE. NO PHYSIOLOGICAL EFFECT WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THIS ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR INSULIN INFUSION SET| INSULIN