BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2026707 · Received March 18, 2011

    Report

    Report Number
    2531779-2011-01725
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 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

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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 ALLEGED THAT A CARTRIDGE LEAKAGE RESULTED IN BLOOD GLUCOSE OF 330MG/DL WITHOUT REPORTED SYMPTOMS OF HYPERGLYCEMIA. HE REPORTED THAT HE CORRECTED THE ELEVATED BLOOD GLUCOSE VIA SYRINGE ACCORDING TO THIS HEALTH CARE PROVIDER'S PROTOCOL. THE PATIENT NOTED THAT WITHIN AN HOUR HIS BLOOD GLUCOSE RETURNED TO LESS THAN 250MG/DL. HE SAID THAT HE REMOVED HIMSELF FROM THE PUMP; HE HAS A PLAN FOR USE OF RAPID-ACTING INSULIN AS WELL AS LONG-ACTING INSULIN. THE PATIENT STATED THAT HE WILL RE-START PUMP THERAPY AFTER HE RECEIVES 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 19 YR