BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2076481 · Received April 1, 2011

    Report

    Report Number
    2531779-2011-01968
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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 DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CLAIMED THAT THE CARTRIDGE FROM LOT# B201576 IS LEAKING. THERE WAS REPORT OF THE PATIENT'S BLOOD GLUCOSE ELEVATED IN THE "250-300 MG/DL" RANGE. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR HAVE ANY KETONES THAT WOULD SUGGEST A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED CARTRIDGE LEAKAGE ISSUE FOR LOT# B201576.

    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 B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR