BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1052851 · Received May 27, 2008

    Report

    Report Number
    2183996-2008-00765
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 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
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE RECEIVED AN E6 (MECHANICAL) ERROR ON HER INFUSION DEVICE DURING A CARTRIDGE CHANGE. TO TROUBLESHOOT SHE WAS ADVISED TO REMOVE THE INSULIN CARTRIDGE FROM THE INFUSION DEVICE. THE PLUNGER OF THE INSULIN CARTRIDGE BECAME STUCK TO THE PISTON ROD CAUSING INSULIN TO SPILL INTO THE CARTRIDGE COMPARTMENT. SHE DRIED THE INSULIN WITH A COTTON SWAB AND THEN RECEIVED AN E2 (BATTERY DEPLETED) ERROR. THE PT INSERTED A NEW BATTERY AND WAS ABLE TO EXTEND THE PISTON ROD TO REMOVE THE STUCK PLUNGER. SHE THEN RETRACTED THE PISTON ROD, INSERTED A NEW INSULIN CARTRIDGE, AND PRIMED THE INFUSION SET. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL 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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET