BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1192446 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01539
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 29, 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
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT STATED THAT ON SIXTEEN DAYS LATER, HE CHANGED THE INSULIN CARTRIDGE AND INFUSION SET AND HAD A DIFFICULT TIME PRIMING. HE STATED THAT THE PISTON ROD STOPPED DURING THE PRIME. HE REMOVED AND REINSERTED THE INSULIN CARTRIDGE AND WAS ABLE TO COMPLETE THE PRIME. HE ALSO STATED THAT HE RECEIVED AN E10 (CARTRIDGE ) ERROR. LATER IN THE DAY, THE PT'S BLOOD GLUCOSE ELEVATED TO OVER 600 MG/DL AND HE WAS "SICK" AND COULD "BARELY WALK." HE THEN NOTICED THAT THE DISPLAY OF THE INFUSION DEVICE WAS "UNREADABLE" AND "THE PISTON ROD WAS NOT WORKING." HE CHANGED THE BATTERY BUT WAS UNABLE TO CORRECT THE ISSUE. HE INJECTED 15 UNITS OF INSULIN AND SWITCHED TO HIS BACKUP INFUSION DEVICE. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO INSERT A BATTERY AND HE RECEIVED AN ERROR AND THE DISPLAY "SAID SOMETHING ABOUT POWER." THE PT WAS NOT ABLE TO REVIEW THE ALARM HISTORY DUE TO THE UNREADABLE DISPLAY. THE INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO MOISTURE. 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 Other| R INSULIN INFUSION SET| INSULIN