BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1193209 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01495
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    July 19, 2008
    Report Date
    September 19, 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
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT FOR THE PAST 2 MONTHS HE HAS ISSUES WITH THE PISTON ROD OF HIS INFUSION DEVICE STICKING AND CAUSING E4 (OCCLUSION) ERRORS. HE IS ABLE TO CLEAR THE ERROR BY RETRACTING THE PISTON ROD AND RESETTING THE INFUSION DEVICE FOR A PARTIAL INSULIN CARTRIDGE. HE STATED THAT HE CAN HEAR A GRINDING NOISE COMING FROM THE INFUSION DEVICE. THE INFUSION DEVICE HAS NOT BEEN DROPPED OR EXPOSED TO EXTREME TEMPERATURES OF MOISTURE. HE STATED THAT LAST WEEK HE PASSED THE INFUSION DEVICE THROUGH THE X-RAY IN THE AIRPORT, HOWEVER, HE HAD ALREADY BEEN EXPERIENCING THESE ISSUES. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OF 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 35 YR INSULIN| INSULIN INFUSION SET