BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1082067 · Received July 23, 2008

    Report

    Report Number
    2183996-2008-01092
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 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
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT THE INFUSION DEVICE DISPLAYED E8 (POWER INTERRUPT) AND THEN E6 (MECHANICAL) ERROR. THE BATTERY HAD BEEN IN USED FOR 1 WEEK. THE PT REMOVED AND REINSERTED THE BATTERY AND PERFORMED THE CHANGE CARTRIDGE PROCEDURE. THE INFUSION DEVICE ALARMED E6 WHILE ATTEMPTING TO PRIME THE INFUSION TUBING. SHE STATED THAT THE PISTON ROD ONLY MOVES A LITTLE AND "MAKES A CRAZY NOISE" AND THE INFUSION DEVICE ALARMS E10 (CARTRIDGE ERROR). THE PT STATED THAT THE INFUSION DEVICE HAD NOT BEEN DROPPED OR EXPOSED TO WATER. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT WAS ADVISED TO SWITCH TO HER BACKUP INFUSION DEVICE. THE PT 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 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 INFUSION SET| INSULIN