BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1163428 · Received September 10, 2008

    Report

    Report Number
    2183996-2008-01362
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 26, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PATIENT REPORTED THAT THE PISTON ROD OF HER INFUSION DEVICE WAS STUCK AT THE BOTTOM OF THE CARTRIDGE COMPARTMENT. SHE STATED THAT SHE NOTICED THIS APPROXIMATELY A WEEK AND A HALF AGO DURING BASAL DELIVERY. SHE STATED THAT SHE CAN HEAR THE PISTON ROD CLICK, BUT IT DOES NOT MOVE. SHE STATED THAT THE INFUSION DEVICE WAS DROPPED, BUT INSULIN MAY HAVE BEEN SPILLED IN THE CARTRIDGE COMPARTMENT. THE PATIENT SWITCHED TO HER BACKUP INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO 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 38 YR INSULIN INFUSION SET| INSULIN