BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1243165 · Received November 7, 2008

    Report

    Report Number
    2183996-2008-01702
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 31, 2008
    Report Date
    October 31, 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
    GA, 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 SHE CONTINUES TO EXPERIENCE AIR BUBBLES IN HER INSULIN CARTRIDGES. SHE STATED THAT SHE PROPERLY ADJUSTS THE PISTON ROD AND ALLOWS INSULIN TO REACH ROOM TEMPERATURE PRIOR TO USE. SHE ATTEMPTS TO PRIME AIR BUBBLES FROM THE SYSTEM BUT THEY ARE POSITIONED SO THAT SHE IS UNABLE TO REMOVE THEM. THE PATIENT WAS EXPERIENCING AIR BUBBLES AT THE TIME OF THE REPORT, AND SHE HAD ATTEMPTED TO PRIME SEVERAL TIMES TO REMOVE THEM BUT WAS UNSUCCESSFUL. SHE REQUESTED FURTHER 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 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| INSULIN INFUSION PUMP| INSULIN INFUSION SET