BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1243178 · Received November 7, 2008

    Report

    Report Number
    2183996-2008-01689
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 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

    IN 2008, THE PT'S SON REPORTED THAT THE PT CONTINUES TO EXPERIENCE AIR BUBBLES IN THE INSULIN CARTRIDGE. HE STATED THAT LAST WEEK HE AND HIS MOTHER PARTICIPATED IN A TRAINING SESSION AND WERE EDUCATED ON FILLING THE INSULIN CARTRIDGE. THE SON STATED THAT THE TRAINER FILLED THE INSULIN CARTRIDGE THAT THE PT IS CURRENTLY USING AND THERE ARE AIR BUBBLES PRESENT. THE SON STATED THAT HE FILLS THE PT'S INSULIN CARTRIDGES AS THE TRAINER INSTRUCTED AND HE USES ROOM TEMPERATURE INSULIN. HE STATED THAT HE DOES ADJUST THE PISTON ROD PRIOR TO INSERTING THE INSULIN CARTRIDGE INTO THE INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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 72 YR INSULIN| INSULIN INFUSION SET