BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2038505 · Received March 22, 2011

    Report

    Report Number
    2531779-2011-01894
    Event Type
    Injury
    Date Received
    March 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 REPORTER REPORTED THAT ON APPROXIMATELY (B)(6) 2011 AT 3 AM, THE PATIENT OBTAINED THE BLOOD GLUCOSE LEVEL OF 'HI MG/DL' (GREATER THAN 600 MG/DL) AND EXPERIENCED THE SYMPTOM OF NAUSEA. THE PATIENT CHANGED THE INFUSION SITE AND INSULIN CARTRIDGE AND REPORTED WAS ABLE TO LOWER HER BLOOD GLUCOSE LEVELS THREE HOURS LATER. SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT NOTED THERE WERE AIR BUBBLES IN THE CARTRIDGE, AND THE PUMP'S CARTRIDGE COMPARTMENT SMELLED OF INSULIN. TROUBLESHOOTING REVEALED THE PATIENT FOUND NO LEAKS OR KINKS IN THE TUBING, HER TECHNIQUE WAS CORRECT, THE TOTAL BASAL/BOLUS INSULIN DELIVERED WAS CORRECT AND THE PUMP PROGRAMMING WAS CORRECT.

    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 Life Threatening| R