BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTHER

    MDR report key: 2082062 · Received May 9, 2011

    Report

    Report Number
    2531779-2011-03235
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1, 06/03/2011 - DEVICE EVALUATION: 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 # B201582 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    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 FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. BRAND NAME: ANIMAS INSULIN CARTRIDGE. CORRECTION NUMBER: 2531779-02/25/11-001-R.

    Description of Event or Problem · 1

    THE REPORTER ALLEGED THAT THE ANIMAS CARTRIDGE WITH LOT# B201582 HAS LEAKAGE ISSUE. THE PATIENT REPORTEDLY NOTICED THE LEAKING AT THE PLUNGER SIDE OF THE CARTRIDGE AND WETNESS IN THE CARTRIDGE COMPARTMENT OVER THE LAST 2 WEEKS. THERE WAS BLOOD GLUCOSE EXCURSION. IN ADDITION, THERE WAS NO REPORT OF ANY MEDICAL INTERVENTION OR SYMPTOMS THAT WOULD SUGGEST A SERIOUS INJURY OCCURRED. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED CARTRIDGE LEAKAGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTHER INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201582

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR