BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRITI

    MDR report key: 1172182 · Received September 18, 2008

    Report

    Report Number
    2183996-2008-01432
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 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
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THE PLUNGER OF THE INSULIN CARTRIDGE BECAME STUCK TO THE PISTON ROD OF THE INFUSION DEVICE AND 5-6 UNITS OF INSULIN SPILLED INTO THE CARTRIDGE COMPARTMENT. THE PATIENT WAS ABLE TO REMOVE THE PLUNGER FROM THE PISTON ROD. SHE WAS INSTRUCTED TO DRY THE CARTRIDGE COMPARTMENT WITH A COTTON SWAB. SHE WAS EDUCATED ON THE PROPER TECHNIQUE FOR REMOVING THE INSULIN CARTRIDGE FROM THE INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OF SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR INSULIN INFUSION SET| INSULIN