BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2060744 · Received April 8, 2011

    Report

    Report Number
    2531779-2011-02374
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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# 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

    ON (B)(6) 2011, THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PT) ALLEGING A LEAKING CARTRIDGE ISSUE. THE REPORTER CLAIMED THAT DURING THE TIME OF CONCERN, THE PT DEVELOPED A BLOOD GLUCOSE (BG) LEVEL IN THE "400'S" MG/DL. HOWEVER, THE REPORTER DENIED THAT THE PT DEVELOPED SYMPTOMS. AT ONE POINT, THE PT REPORTEDLY COMPLAINED ABOUT HAVING A WET CARTRIDGE. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PT HAD A LEAKING CARTRIDGE ISSUE. THERE IS NO EVIDENCE HOWEVER THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PT DID NOT HAVE ANY BG READINGS OR SYMPTOMS THAT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY.

    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