BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2059498 · Received April 7, 2011

    Report

    Report Number
    2531779-2011-02416
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    Removal / Correction Number
    2531779-02/25/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT# B201583 FROM THE RETAINS 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 CLAIMED THAT THE INSULIN CARTRIDGE WITH LOT# B201583 WAS LEAKING. REPORTEDLY, THE PT'S BLOOD GLUCOSE ELEVATED TO "400 MG/DL" WITHOUT ANY SYMPTOMS UPON THE DISCOVERY OF THE REPORTED ISSUE. FURTHERMORE, THE PT DID NOT REQUIRE ANY MEDICAL INTERVENTION FOR ACUTE COMPLICATIONS OF DIABETES. THE PT'S BLOOD GLUCOSE WAS WITHIN THE TARGET RANGE OF "120-160 MG/DL" AFTER A CORRECTION INSULIN BOLUS WAS ADMINISTERED. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTIONED DUE TO THE ALLEGED CARTRIDGE LEAKAGE. THERE WAS NO EVIDENCE OF A SERIOUS INJURY AS THE PT DID NOT HAVE ANY SYMPTOMS AND DID NOT RECEIVE ANY MEDICAL INTERVENTION TO SUGGEST ACUTE COMPLICATION OF DIABETES.

    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 B201583

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR