BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1033716 · Received April 25, 2008

    Report

    Report Number
    2183996-2008-00589
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 20, 2008
    Report Date
    April 20, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT BOLUSED 5.5 UNITS OF INSULIN AT 6:45PM. HER BLOOD GLUCOSE MEASURED 135MG/DL. APPROX 1.5 HOURS LATER, THE PT'S BLOOD GLUCOSE ELEVATED TO 400MG/DL AND SHE HAD A DRY MOUTH AND A HEADACHE. SHE INSPECTED THE INFUSION DEVICE AND FOUND INSULIN HAD LEAKED FROM THE INSULIN CARTRIDGE INTO THE CARTRIDGE COMPARTMENT. SHE DRIED THE CARTRIDGE COMPARTMENT WITH A COTTON SWAB AND INSERTED A NEW INSULIN CARTRIDGE. INSULIN THEN LEAKED FROM THE SECOND INSULIN CARTRIDGE. SHE INSERTED A THIRD INSULIN CARTRIDGE AND INSULIN LEAKED AGAIN. THE PT WAS NOT ABLE TO PROVIDE THE LOT NUMBER OF THE INSULIN CARTRIDGE. SHE STATED THEY WERE ALL FROM THE SAME BOX. AT 9:15PM, THE PT'S BLOOD GLUCOSE MEASURED "HI" ON HER BLOOD GLUCOSE MONITOR AND SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND BOLUSED 6 UNITS OF INSULIN. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R INSULIN INFUSION SET| INSULIN INFUSION PUMP| INSULIN