BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1162774 · Received September 8, 2008

    Report

    Report Number
    2183996-2008-01328
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT, WHILE REMOVING THE INSULIN CARTRIDGE FROM HER INFUSION DEVICE, THE PLUNGER REMAINED ATTACHED TO THE PISTON ROD IN THE CARTRIDGE CHAMBER. THIS CAUSED 200 UNITS OF INSULIN TO SPILL INTO THE CARTRIDGE CHAMBER. PROPER REMOVAL OF THE INSULIN CARTRIDGE FROM THE CHAMBER WAS REVIEWED WITH THE PATIENT. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. 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 30 YR INSULIN INFUSION SET| INSULIN