BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1163408 · Received September 10, 2008

    Report

    Report Number
    2183996-2008-01376
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 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
    CO, 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 EXPERIENCING AIR BUBBLES IN HIS INSULIN CARTRIDGES. HE STATED THAT HE USES ROOM TEMPURATURE INSULIN. HE STATED THAT IF HE IS NOT ABLE TO REMOVE THE AIR BUBBLES WHILE FILLING THE INSULIN CARTRIDGE HE TRIES TO REMOVE THE BUBBLES WHILE PRIMING THE INFUSION TUBING. HE WAS EDUCATED ON THE PROPER INSULIN CARTRIDGE FILLING TECHNIQUE AND ADVISED TO PRIME WITH THE ADAPTER OF THE INFUSION DEVICE UPRIGHT. THE PATIENT DECLINED ASSISTANCE FROM A TRAINER. 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 WILL 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 50 YR INSULIN| INSULIN INFUSION SET| INSULIN INFUSION PUMP