BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1051275 · Received May 22, 2008

    Report

    Report Number
    2183996-2008-00756
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 15, 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 05/15/2008 THE PT REPORTED THAT SHE IS EXPERIENCING AIR BUBBLES IN HER INSULIN CARTRIDGE. SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND HAD NO ISSUES WITH AIR BUBBLES FORMING. SHE SWITCHED BACK TO HER PRIMARY INFUSION DEVICE AND STATED THAT THE BUBBLES BEGAN TO FORM IMMEDIATELY AFTER THE INSULIN CARTRIDGE WAS INSERTED. SHE STATED THAT A GAP OF AIR FORMED AT THE TOP OF THE INSULIN CARTRIDGE. SHE STATED THAT SHE USES ROOM TEMPERATURE INSULIN AND INSERTS THE INSULIN CARTRIDGE INTO THE INFUSION DEVICE PER THE USER'S MANUAL. 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 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