BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2075196 · Received March 30, 2011

    Report

    Report Number
    2531779-2011-02163
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Report Date
    February 28, 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
    OH, 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. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED, THERE IS NOT 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

    THE RPTR REPORTED THAT THE PT OBTAINED ELEVATED BLOOD GLUCOSE READINGS SUCH AS GREATER THAN 300 MG/DL, AND NOTED THAT SHE COULD SMELL INSULIN IN THE CARTRIDGE COMPARTMENT. THE PT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS AND DID NOT SEEK ANY MEDICAL ATTENTION. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS 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 B201581

    Patients

    Seq Age Sex Outcome Treatment
    1