BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2061196 · Received April 4, 2011

    Report

    Report Number
    2531779-2011-02104
    Event Type
    Injury
    Date Received
    April 4, 2011
    Report Date
    March 2, 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
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201583 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER SON (THE PATIENT) ALLEGING LEAKING CARTRIDGES. AS A RESULT OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS HAVE REACHED THE "400-500 MG/DL" RANGE. WITHIN THE PREVIOUS 6 MONTHS, THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED KETONES TWICE BECAUSE OF THE LEAKING CARTRIDGE ISSUE. THE REPORTER DENIED THAT THE PATIENT RECEIVED MEDICAL INTERVENTION DUE TO THE ALLEGED ISSUE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPERGLYCEMIA DUE TO A LEAKING CARTRIDGE ISSUE.

    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 Life Threatening