BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1003223 · Received February 21, 2008

    Report

    Report Number
    2183996-2008-00189
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 THAT WHILE CHANGING HIS INSULIN CARTRIDGE THE PLUNGER BECAME STUCK IN THE PISTON ROD AND INSULIN SPILLED INSULIN INTO THE CARTRIDGE COMPARTMENT. HE WAS INSTRUCTED HOW TO REMOVE THE PLUNGER FROM THE PISTON ROD AND TO DRY THE COMPARTMENT WITH A COTTON SWAB. HE WAS ADVISED TO ALLOW THE INFUSION DEVICE TO DRY, AND HE SWITCHED TO HIS BACKUP INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. UPON FOLLOW UP ON THREE DAYS LATER, THE PATIENT STATED THAT HE WAS DOING WELL AND HE HAD NOT YET SWITCHED BACK TO HIS PRIMARY INFUSION DEVICE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR 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 SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET