BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1250018 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01716
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B) (6) 2008 THE PATIENT REPORTED THAT, WHILE CHANGING THE INSULIN CARTRIDGE OF HER INFUSION DEVICE, THE PLUNGER REMAINED ATTACHED TO THE PISTON ROD IN THE CARTRIDGE CHAMBER. THE PATIENT SAID SHE THINKS A FEW UNITS OF INSULIN SPILLED OUT INTO THE CARTRIDGE CHAMBER. DURING TROUBLESHOOTING WITH A COMPANY REPRESENTATIVE, THE PLUNGER WAS DETACHED FROM THE PISTON ROD. THE PATIENT WAS INSTRUCTED TO DRY OUT THE CHAMBER WITH A COTTON SWAB. 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 46 YR INSULIN INFUSION SET| INSULIN