BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1163427 · Received August 10, 2008

    Report

    Report Number
    2183996-2008-01363
    Event Type
    Malfunction
    Date Received
    August 10, 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
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PATIENT REPORTED THAT THE PLUNGER OF THE INSULIN CARTRIDGE BECAME STUCK TO THE PISTON ROD OF THE INFUSION DEVICE. SHE WAS ABLE TO REMOVE THE PLUNGER FROM THE PISTON ROD. SHE WAS EDUCATED ON THE PROPER PROCEDURE FOR CARTRIDGE REMOVAL. SHE STATED THAT A SMALL AMOUNT OF INSULIN SPILLED INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. NO PRODUCT WILL 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 * INSULIN INFUSION SET| INSULIN