BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1942403 · Received December 23, 2010

    Report

    Report Number
    2531779-2010-03076
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010/003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED AN EVAL WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE PUMP DISPENSED INSULIN FROM THE CARTRIDGE DURING AN "EZPRIME" OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1