BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1132472 · Received August 22, 2008

    Report

    Report Number
    2183996-2008-01280
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT INSULIN LEAKED FROM THE INSULIN CARTRIDGE INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE INSULIN CARTRIDGE HAD BEEN IN USE FOR 2 DAYS. SHE STATED THAT SHE RETRACTED THE PISTON ROD AND ATTEMPTED TO DRY THE CARTRIDGE COMPARTMENT BUT INSULIN WAS STILL VISIBLE BELOW THE PISTON ROD. SHE SWITCHED TO HER BACKUP INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 476747

    Patients

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