BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3035274 · Received April 4, 2013

    Report

    Report Number
    2531779-2013-03586
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2013 DEVICE EVALUATION: A RETAINED CARTRIDGE FROM LOT # B201904 WAS EVALUATED. A LEAK TEST WAS PERFORMED WITH NO FAILURE OBSERVED. NO LEAKS WERE OBSERVED FROM THE LUER LOCK CONNECTION, O-RINGS OR ELSEWHERE ON THE CARTRIDGE.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. 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 AN ISSUE WITH AIR BUBBLES SINCE (B)(6) 2013 WHEN USING NEW BOXES OF CARTRIDGES AND INFUSION SETS. THE PATIENT REPORTED USING ROOM TEMPERATURE INSULIN AND LEFT THE CARTRIDGE TO DE-BUBBLE FOR 30 MINUTES PRIOR TO PRIMING THE TUBING. TROUBLESHOOTING CONFIRMED THAT THE PATIENT WAS USING THE CARTRIDGE AND INFUSION SET PER THE INSTRUCTIONS FOR USE. THE PATIENT INDICATED THAT BUBBLES DEVELOPED AT THE NECK OF THE CARTRIDGE GOING IN TO INFUSION SET. THE PATIENT CONFIRMED THAT THE CONNECTIONS WERE TIGHT AND CONFIRMED THAT THERE WERE NO ISSUES NOTED WITH THE SITES WHEN REMOVED. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE AIR BUBBLES ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138800 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION B201904

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR