BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3111774 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06358
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE RETAINED CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE RETAINED CARTRIDGE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS NOTED IN THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED. THERE WERE NO LEAKS OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PATIENT CONTACTED ANIMAS ALLEGING ISSUES WITH FILLING THE CARTRIDGES AND STATED THAT THE CARTRIDGES ARE LEAKING. TROUBLESHOOTING INDICATED THE PLUNGER CAME LOOSE FROM THE BACK END OF THE CARTRIDGE AND THE PATIENT RE-INSERTED THE PLUNGER. CUSTOMER TECHNICAL SUPPORT ADVISED THE PATIENT THAT THIS IS AGAINST THE INSTRUCTIONS FOR USE, BUT THE PATIENT STATED SHE BELIEVES IT IS A CARTRIDGE ISSUE AND REQUESTED TWO CARTRIDGES BE REPLACED. THE PATIENT HAD REPORTEDLY DISCARDED THE CARTRIDGE, SO THEY WERE UNAVAILABLE FOR TROUBLESHOOTING. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE CARTRIDGES WERE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212407 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION B201954

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR