BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1021517 · Received March 26, 2008

    Report

    Report Number
    2183996-2008-00394
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 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
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT STATED THAT, WHILE REMOVING THE INSULIN CARTRIDGE FROM HIS INFUSION DEVICE, THE PLUNGER REMAINED ATTACHED TO THE PISTON ROD IN THE CARTRIDGE CHAMBER. HE STATED THE ENTIRE CARTRIDGE OF INSULIN SPILLED INTO THE CARTRIDGE COMPARTMENT. DURING TROUBLESHOOTING WITH A CO REP, THE PLUNGER WAS DETACHED FROM THE PISTON ROD. PROPER REMOVAL OF THE INSULIN CARTRIDGE FROM THE CHAMBER WAS REVIEWED WITH THE PT. THE PT WAS ADVISED TO SWITCH TO ALTERNATIVE INSULIN 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. THE PROD WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    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| INSULIN INFUSION SET