BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCHEK SPIRIT

    MDR report key: 1082049 · Received July 23, 2008

    Report

    Report Number
    2183996-2008-01088
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT STATED THAT, WHILE REMOVING THE INSULIN CARTRIDGE FROM HIS INFUSION DEVICE, THE PLUNGER REMAINED ATTACHED TO THE PISTON ROD IN THE CARTRIDGE CHAMBER. THIS CAUSED A FULL CARTRIDGE OF INSULIN TO SPILL INTO THE CARTRIDGE CHAMBER. DURING TROUBLESHOOTING WITH A COMPANY REPRESENTATIVE, THE PT WAS INSTRUCTED IN HOW TO DETACH THE PLUNGER FROM THE PISTON ROD. PROPER REMOVAL OF THE INSULIN CARTRIDGE FROM THE CHAMBER WAS REVIEWED WITH THE PT. THE PT STATED HE WOULD SWITCH ITO INJECTION THERAPY UNTIL THE REPLACEMENT ARRIVES. 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 EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUCHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INSULIN| INSULIN INFUSION SET