BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4006246 · Received August 13, 2014

    Report

    Report Number
    2531779-2014-23296
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Report Date
    August 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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

    CORRECTION: SUSPECT MEDICAL DEVICE: THE INITIAL REPORT WAS INADVERTENTLY SUBMITTED AGAINST THE PUMP. THE SUSPECT MEDICAL DEVICE HAS BEEN CHANGED TO THE INSULIN CARTRIDGE. BRAND NAME: ANIMAS INSULIN CARTRIDGE, DEVICE NAME: INSULIN PUMP CARTRIDGE, MFG DATE: (B)(4), PMA/510K NUMBER: K032257.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A LOSS OF PRIME ISSUE WITH THE PUMP. 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
    482422 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR