BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1120963 · Received August 13, 2008

    Report

    Report Number
    2183996-2008-01210
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 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
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT, WHILE REMOVING THE INSULIN CARTRIDGE FROM HER INFUSION DEVICE, THE PLUNGER REMAINED ATTACHED TO THE PISTON ROD IN THE CARTRIDGE CHAMBER. THIS CAUSED A SMALL AMOUNT OF INSULIN TO SPILL INTO THE CARTRIDGE CHAMBER. SHE SAID SHE WILL USE A DRY CLOTH TO DRY THE CHAMBER OUT. DURING TROUBLESHOOTING WITH A COMPANY REPRESENTATIVE, THE PLUNGER WAS DETACHED FROM THE PISTON ROD. PROPER REMOVAL OF THE INSULIN CARTRIDGE FROM THE CHAMBER WAS REVIEWED WITH THE PATIENT. THE PATIENT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS 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 INSULIN INFUSION SET| INSULIN