BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1970402 · Received January 18, 2011

    Report

    Report Number
    2531779-2011-00313
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 18, 2010
    Manufacturer
    ANIMAS CORP.
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DISPENSED INSULIN DURING THE LOAD CARTRIDGE STEP. A FAMILY MEMBER REPORTED THAT SHE WAS CHANGING THE CARTRIDGE AND THE PATIENT WAS DISCONNECTED FROM THE INFUSION SET WHEN THE ALLEGED MALFUNCTION OCCURRED. SHE STATED THAT SHE ATTEMPTED TO COMPLETE THE PROCESS AGAIN WITH TWO CARTRIDGES FROM TWO DIFFERENT BOXES WITH THE SAME RESULT. THE FAMILY MEMBER SAID THAT THE PUMP DISPLAYS A MESSAGE THAT THE PUMP IS NOT PRIMED OR THAT NO CARTRIDGE IS DETECTED. SHE DENIED KNOWN TRAUMA TO PUMP OR OTHER PROBLEMS WITH PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR