BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2026715 · Received March 18, 2011

    Report

    Report Number
    2531779-2011-01723
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT #B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT FIVE CARTRIDGES FROM THE SAME SHIPMENT, BUT DIFFERENT BOXES HAVE LEAKED WHERE THE PLUNGER MEETS THE BARREL OF THE CARTRIDGE. HE OBSERVED THAT INSULIN COLLECTED INSIDE THE PLUNGER AND OUTSIDE THE BARREL. THE PATIENT STATED THAT HE DOES NOT REMOVE THE PLUNGERS FROM THE CARTRIDGES; HE NEVER RE-USES CARTRIDGES; HE FILLS THEM TO 200 UNITS, BUT NEVER OVERFILLS THE CARTRIDGE. HE NOTED THAT THE CARTRIDGE COMPARTMENT WAS WET, BUT THERE WAS NO VISIBLE INSULIN UNDER THE DISPLAY LENS. THE PATIENT SUSPENDED INSULIN PUMP THERAPY AND USED AN ALTERNATE METHOD OF INSULIN DELIVERY UNTIL HE RECEIVED A NEW BOX OF CARTRIDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/2020/OTP B201581

    Patients

    Seq Age Sex Outcome Treatment
    1