BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1051273 · Received May 22, 2008

    Report

    Report Number
    2183996-2008-00760
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 20, 2008
    Report Date
    May 20, 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
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON 05/20/08 THE PT STATED THAT FOR THE PAST 2 MONTHS SHE HAS EXPERIENCED AIR BUBBLES IN HER INSULIN CARTRIDGES. SHE STATED THAT THE AIR BUBBLES APPEAR AFTER THE INSULIN CARTRIDGE IS PLACED INTO THE INFUSION DEVICE. SHE PERFORMS A PRIME TO REMOVE THE AIR BUBBLES. SHE STATED THAT SHE ALLOWS INSULIN TO REACH ROOM TEMPERATURE BEFORE USE. SHE DOES NOT ADJUST THE PISTON ROD OF THE INSULIN DEVICE BEFORE INSERTING THE INSULIN CARTRIDGE AND SHE DOES NOT ATTACH THE ADAPTER OR INFUSION TUBING PRIOR TO INSERTION. SHE WAS EDUCATED ON THE PROPER PROCEDURE. 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 CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

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