BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 889351 · Received August 3, 2007

    Report

    Report Number
    2183996-2007-01158
    Event Type
    Malfunction
    Date Received
    August 3, 2007
    Date of Event
    July 23, 2007
    Report Date
    July 23, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K042887
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PT REPORTED THAT "PLEASE REMOVE THE CARTRIDGE" IS STUCK ON THE DISPLAY SCREEN OF HER INSULIN INFUSION DEVICE. THE PT WAS ADVISED THIS IS A NORMAL PART OF CHANGING THE CARTRIDGE. DURING TROUBLESHOOTING AND WHILE TRYING TO REMOVE THE DISPLAY BY PUTTING IN THE INSULIN CARTRIDGE, THE PT GOT THE CARTRIDGE PLUNGER STUCK ON THE PISTON ROD. THE PT WAS EDUCATED ON HOW TO REMOVE THE PLUNGER FROM THE PISTON ROD. THE PT STATED THAT, AS A RESULT OF THE PLUNGER BEING STUCK ON THE PISTON ROD, SOME INSULIN WAS IN THE CARTRIDGE COMPARTMENT. SHE WAS ADVISED TO DRY OUT THE COMPARTMENT WITH A DRY SOFT CLOTH OR Q-TIP. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO 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, INC. ACCU-CHEK SPIRIT NA

    Patients

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