BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1122334 · Received August 15, 2008

    Report

    Report Number
    2183996-2008-01237
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT STATED THAT THE PLUNGER REMAINED ATTACHED TO THE PISTON ROD IN THE CARTRIDGE CHAMBER OF HER INSULIN INFUSION DEVICE. SHE STATED SHE WAS CHANGING THE INSULIN CARTRIDGE AND PLACED HER NEWLY FILLED CARTRIDGE IN THE DEVICE WITH THE PROTECTIVE CAP ON THE END. SHE SAID SHE DID NOT ATTACH THE TUBING TO THE END OF HER CARTRIDGE. WHEN SHE TRIED TO PULL THE CAP OFF THE CARTRIDGE, THE CARTRIDGE CAME OUT AND INSULIN SPILLED INTO THE CARTRIDGE CHAMBER. SHE SAID SHE CLEANED OUT ALL THE INSULIN WITH A TISSUE. PROPER INSERTION AND REMOVAL OF THE INSULIN CARTRIDGE FROM THE CHAMBER WAS REVIEWED WITH THE PATIENT. ON FOLLOW UP WITH THE PATIENT, SHE STATED HER DEVICE IS PROPERLY WORKING AND SHE HAS HAD NO FURTHER MOISTURE INSIDE THE DEVICE. 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 54 YR INSULIN| INSULIN INFUSION SET