BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT INSULIN CARTRIDGE

    MDR report key: 1030788 · Received April 17, 2008

    Report

    Report Number
    2183996-2008-00481
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE NOTICED AN AIR BUBBLE HER INSULIN CARTRIDGE. SHE STATED THAT SHE USES ROOM TEMPERATURE INSULIN AND SHE LUBRICATED THE INSULIN CARTRIDGE PRIOR TO FILLING. SHE STATED THAT THE AIR BUBBLES ARE NOT PRESENT WHEN SHE INSERTS THE INSULIN CARTRIDGE INTO THE INFUSION DEVICE THEY APPEAR LATER. THROUGH TROUBLESHOOTING, IT WAS DISCOVERED THAT THE ADAPTER WAS NOT PROPERLY TIGHTENED. THE PT WAS ASSISTED WITH PRIMING THE AIR BUBBLE OUT OF THE SYSTEM. UPON FOLLOW UP ON TWO DAYS LATER, THE PT STATED THAT SHE HAD NO FURTHER ISSUES. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

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