BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IACCU-CHEK SPIRIT

    MDR report key: 1003215 · Received February 20, 2008

    Report

    Report Number
    2183996-2008-00181
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 8, 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

    THE PATIENT REPORTED SHE REC'D AN E10 (CARTRIDGE ERROR) MESSAGE ON HER INSULIN INFUSION DEVICE. SHE STATED THAT PRIOR TO CALLING AND WHILE CHANGING HER INSULIN CARTRIDGE, THE DEVICE MADE A GRINDING NOISE WHEN THE PISTON ROD RETRACTED AND THEN IT ALARMED E10. SHE SAID SHE THEN REPLACED THE BATTERY. TO TROUBLESHOOT, THE PT WAS ASKED TO REPEAT THIS PROCESS TWICE AND BOTH TIMES THE DEVICE AGAIN MADE THE GRINDING NOISE AND THE E10 REOCCURRED. 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. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NSULIN INFUSION SET| INSULIN