BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1983203 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00592
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 REBOOTED WITHOUT USER INTERVENTION; THE SCREEN FROZE ON THE ANIMAS LOGO DISPLAY WHEN THE PUMP POWERED UP. A FAMILY MEMBER STATED THAT THE PATIENT WAS NOT DOING ANYTHING WITH PUMP THAT WOULD CAUSE IT TO REBOOT. SHE SAID THAT A REPLACE BATTERY ALARM WAS NOT RECEIVED AND NO OTHER ALARMS WERE REPORTED. THE FAMILY MEMBER SAID THAT THEY NOTICED THE PROBLEM IMMEDIATELY AS THE PATIENT AND SHE WERE TOGETHER IN THE CAR AT THE TIME OF THE EVENT; SHE DID NOT REPORT ANY BLOOD GLUCOSE EXCURSIONS DUE TO THIS ISSUE.

    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 15 YR