BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3802781 · Received May 9, 2014

    Report

    Report Number
    2531779-2014-13105
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DISTRIBUTOR CONTACTED ANIMAS FOR AN UNRELATED ISSUE AND TROUBLESHOOTING FOUND THAT A LOSS OF PRIME HAD OCCURRED. THE PATIENT WAS REPORTEDLY NOT CONNECTED TO THE PUMP AT THE TIME OF THE LOSS OF PRIME. THE REPORTER NOTED THAT THE PATIENT HAD BEEN RE-FILLING CARTRIDGES, HOWEVER THE CAUSE OF THE LOSS OF PRIME COULD NOT BE DETERMINED DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280845 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1