BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1082051 · Received July 23, 2008

    Report

    Report Number
    2183996-2008-01090
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 7, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED SHE REC'D AN E10 (CARTRIDGE ERROR) ON HER INSULIN INFUSION DEVICE DISPLAY WHILE CHANGING THE CARTRIDGE. SHE CHANGED THE BATTERY WHILE ON THE CALL BUT THE E10 DISPLAYED AGAIN. THE PISTON ROD OF THE INFUSION DEVICE WOULD NOT RETURN COMPLETELY. THE PT MENTIONED A LARGE AMOUNT OF INSULIN SPILLED INTO THE CARTRIDGE CHAMBER ON FOUR DAYS EARLIER. THE PT WAS ADVISED TO SWITCH TO HER BACKUP INFUSION DEVICE AND WAS ASSISTED IN SETTING IT UP. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE 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 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET