BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1002996 · Received February 20, 2008

    Report

    Report Number
    2183996-2008-00161
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    February 2, 2008
    Report Date
    February 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE WAS EXPERIENCING AN E6 (MECHANICAL ERROR). SHE STATED THAT THIS IS THE SECOND TIME IN ONE WEEK THAT THIS HAS OCCURRED. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION SITE, AND TO REMOVE THE BATTERY AND CARTRIDGE ASSEMBLY FROM THE INFUSION DEVICE. THE BATTERY WAS LAST CHANGED ON NINE DAYS EARLIER. THE PT WAS INSTRUCTED TO PRIME THE PISTON ROD FORWARD. WHEN SHE REACHED 174 UNITS, THE INFUSION DEVICE ERRORED E6. THE PT WAS VERY UPSET AND STATED HER BLOOD GLUCOSE WAS "EXTREMELY HIGH RIGHT NOW". SHE WAS OFFERED ASSISTANCE WITH SETTING UP HER BACKUP INFUSION DEVICE AND SHE REFUSED. ATTEMPTS TO FOLLOW UP WITH THE PT ON ORIGINAL DATE TO FINISH TROUBLESHOOTING WERE UNSUCCESSFUL. THE PT CALLED FOR ASSISTANCE SETTING UP HER BACKUP INFUSION DEVICE ON THE NEXT DAY. FURTHER ATTEMPTS TO REACH THE PT WERE UNSUCCESSFUL. 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 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 YR Required Intervention INSULIN INFUSION SET| INSULIN