BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1030144 · Received April 15, 2008

    Report

    Report Number
    2183996-2008-00532
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 2, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT'S MOTHER REPORTED THAT THE PT'S INFUSION DEVICE DISPLAYED AN E6 (MECHANICAL) ERROR ONE DAY PRIOR. SHE STATED THAT THE PT WAS UNABLE TO CLEAR THE ERROR. HER BLOOD GLUCOSE ELEVATED AND REGISTERED "HI" ON HER BLOOD GLUCOSE MONITOR. HER NORMAL BLOOD GLUCOSE RANGE IS 90-150 MG/DL. THE PT BOLUSED WITH AN INSULIN PEN BUT HER BLOOD GLUCOSE REMAINED ELEVATED. SHE WAS TAKEN TO THE ER AT THE HOSPITAL WHERE SHE WAS TREATED AND RELEASED (TYPE OF TREATMENT NOT PROVIDED). THE ER PHYSICIAN STATED THAT THE PISTON ROD OF THE INFUSION DEVICE WAS NOT WORKING PROPERLY AND INSTRUCTED THE PT TO SWITCH TO INJECTION THERAPY. TO TROUBLESHOOT THE PT'S MOTHER WAS INSTRUCTED TO PERFORM A CARTRIDGE CHANGE AND THE E6 ERROR CLEARED. DURING PRIMING OF THE INFUSION SET NO INSULIN FLOWED THROUGH THE INFUSION TUBING AND NO ERROR WAS GENERATED. THE INFUSION TUBING WAS DETACHED FROM THE INFUSION DEVICE AND THE MOTHER PERFORMED A PRIME. INSULIN FLOWED FROM THE INSULIN CARTRIDGE WITHOUT ERROR. THE INFUSION DEVICE WAS REPLACED. UPON FOLLOW UP THE NEXT DAY, THE MOTHER REPORTED THAT THE PT VISITED HER PRIMARY PHYSICIAN AND SHE WAS ADVISED TO SWITCH TO HER BACKUP INFUSION DEVICE. HER BLOOD GLUCOSE MEASURED 285 MG/DL AT 3PM. PRODUCT WAS 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 Hospitalization| O| R INSULIN INFUSION SET| INSULIN