BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2504656 · Received March 27, 2012

    Report

    Report Number
    2531779-2012-02465
    Event Type
    Injury
    Date Received
    March 27, 2012
    Report Date
    February 26, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA: 510K #K032257.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CLAIMED HER INSULIN CARTRIDGE HAS A LEAKAGE ISSUE. REPORTEDLY, SHE SMELLS INSULIN AND FELT THE MOISTURE IN THE CARTRIDGE COMPARTMENT. THE PATIENT DID NOT HAVE ANY INCIDENT WITH THE ALLEGED CARTRIDGE BUT CLAIMED THAT IN THE PAST WHEN SHE HAS THE CARTRIDGE LEAKAGE ISSUE, SHE WAS HOSPITALIZED. SHE NOW CLOSELY MONITORS FOR ANY CARTRIDGE ISSUE. THE ALLEGED CARTRIDGE IS BEING RETURNED FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED CARTRIDGE ISSUE AND BECAUSE, THE PATIENT ALLEGEDLY WAS HOSPITALIZED FOR SIMILAR CARTRIDGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization