BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1021834 · Received March 28, 2008

    Report

    Report Number
    2183996-2008-00416
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 9, 2008
    Report Date
    March 9, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT WHILE CHANGING HER INSULIN CARTRIDGE THE PLUNGER BECAME STUCK TO THE PISTON ROD OF THE INFUSION DEVICE AND INSULIN SPILLED INTO THE CARTRIDGE COMPARTMENT. SHE WAS ABLE TO REMOVE THE PLUNGER FROM THE PISTON ROD. SHE WAS EDUCATED ON THE PROPER TECHNIQUE FOR REMOVING THE INSULIN CARTRIDGE. SHE WAS ADVISED TO CLEAN THE CARTRIDGE COMPARTMENT WITH A COTTON SWAB. UPON F/U TWO DAYS LATER, THE PT STATED THAT THE INFUSION DEVICE SHOWS NO SIGNS OF MOISTURE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PROD WILL BE RETURNED FOR EVAL.

    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 INSULIN INFUSION SET| INSULIN