BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1120956 · Received August 13, 2008

    Report

    Report Number
    2183996-2008-01195
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 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
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT AIR BUBBLES ARE FORMING IN THE INSULIN CARTRIDGE OF HIS INFUSION DEVICE. HE STATED THAT NO AIR BUBBLES ARE PRESENT IN THE INSULIN CARTRIDGE UNTIL IT IS INSERTED INTO THE INFUSION DEVICE AND HE PERFORMS A PRIME. HE STATED THAT HE USES ROOM TEMPERATURE INSULIN AND HE ATTACHES THE ADAPTER AND INFUSION TUBING TO THE CARTRIDGE BEFORE INSERTION INTO THE INFUSION DEVICE. HE FILLS THE INSULIN CARTRIDGE TO 230 UNITS AND HE PROPERLY ADJUSTS THE PISTON ROD TO THIS LEVEL. THE PATIENT WAS ADVISED TO SWITCH TO HIS BACKUP INFUSION DEVICE. UPON FOLLOW UP ONE WEEK LATER, THE PATIENT STATED THAT HE DID NOT SWITCH TO HIS BACKUP INFUSION DEVICE AND HE WAS STILL EXPERIENCING AIR BUBBLES. HE REQUESTED ADDITIONAL TRAINING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 INSULIN| INSULIN INFUSION SET| INSULIN INFUSION PUMP