BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2070817 · Received April 15, 2011

    Report

    Report Number
    2531779-2011-02612
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Report Date
    March 19, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED SHE STARTED TO HAVE A PROBLEM WITH HER PUMP POWERING OFF FOR ABOUT ONE WEEK. THE PATIENT STATED WHEN SHE REPLACED THE BATTERY, THE ANIMAS LOGO APPEARED BUT THEN IT WOULD POWER OFF. MULTIPLE BATTERIES AND A NEW BATTERY CAP WERE USED TO TROUBLESHOOT THE POWER ISSUE BUT THE ISSUE PERSISTED. THE PATIENT INDICATED THERE WAS NO PHYSICAL DAMAGE WITH THE PUMP. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. A REPLACEMENT PUMP WAS SENT TO THE PATIENT.

    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