BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1003219 · Received February 20, 2008

    Report

    Report Number
    2183996-2008-00176
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    November 29, 2007
    Report Date
    January 29, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE IS HAVING AN ISSUE WITH AIR BUBBLES DEVELOPING IN HER INSULIN CARTRIDGE A COUPLE OF HOURS AFTER CHANGING THE INFUSION DEVICE CARTRIDGE. SHE STATED SHE TYPICALLY HAS TO PRIME BUBBLES OUT TWICE ON THE DAY SHE CHANGES HER CARTRIDGE AND THEN SHE HAS NO FURTHER ISSUES UNTIL SHE CHANGES THE CARTRIDGE AGAIN. SHE SAID SHE DOES ALLOW THE INSULIN TO REACH ROOM TEMPERATURE BEFORE USING IT. NO BLOOD GLUCOSE CONCERNS WERE REPORTED RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. 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 INSULIN INFUSION PUMP| INSULIN INFUSION SET| INSULIN