BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3102175 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06079
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT WHEN HE WAS PRIMING THE TUBING, HE WAS UNABLE TO GET ANY DROPS TO COME OUT. THE PATIENT STATED HE TRIED TO PRIME AGAIN AND THE SAME THING HAPPENED. THE PATIENT STATED THAT HE DECIDED TO CHANGE THE TUBING AND WHEN HE WAS CHANGING THE TUBING HE NOTICED THAT THERE WAS INSULIN SPILLED IN THE CARTRIDGE COMPARTMENT. THE PATIENT STATED THAT AFTER CHANGING THE TUBING HE WAS ABLE TO PRIME TUBING WITHOUT ANY LEAKS. THE PATIENT BELIEVED THAT THE INSULIN WAS LEAKING FROM THE LUER LOCK CONNECTION BETWEEN THE CARTRIDGE AND TUBING. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE LEAKING CARTRIDGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204560 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR