BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1120163 · Received August 14, 2008

    Report

    Report Number
    2183996-2008-01224
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WHEN SHE TRIED TO PRIME HER INSULIN INFUSION SET TUBING AFTER ATTACHING A NEW TUBING, SHE NOTICED AN AIR BUBBLE IN THE CARTRIDGE OF HER INSULIN INFUSION DEVICE. SHE STATED SHE USES ROOM TEMPERATURE INSULIN TO FILL HER CARTRIDGE. SHE STATED THE AIR BUBBLE WAS NOT THERE PREVIOUSLY AND THINK IT WAS CAUSED BY HER UNSCREWING THE ADAPTER AND REMOVING THE INSULIN CARTRIDGE FROM THE DEVICE TO ATTACH THE NEW TUBING. ON FOLLOW UP WITH THE PATIENT ABOUT 4 DAYS LATER, SHE STATED SHE HAS HAD NO FURTHER ISSUES WITH AIR BUBBLES. THE PATIENT DID NO REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO 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 48 YR INSULIN INFUSION PUMP| INSULIN| INSULIN INFUSION SET