BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1082386 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01101
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 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
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED RECEIVING AN E4 (OCCLUSION) ERROR ON HIS INFUSION DEVICE. TO TROUBLESHOOT THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION SITE AND TO PERFORM A PRIME. HE STATED THAT HE HAD ATTEMPTED TO DO THIS BEFORE THE REPORT BUT HE RECEIVED AN E10 (CARTRIDGE) ERROR. THE PATIENT WAS INSTRUCTED TO REMOVE THE INSULIN CARTRIDGE AND TO PERFORM THE CHANGE CARTRIDGE PROCEDURE. THE PATIENT STATED THAT HE PRESSED AND HELD THE CHECK BUTTON FOR 3 SECONDS AND THE PISTON ROD EXTENDED INSTEAD OF RETRACTED. HE THEN RECEIVED AN E10 ERROR. THE PATIENT WAS INSTRUCTED TO SWITCH TO HIS BACKUP INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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 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 INSULIN INFUSION SET| INSULIN