BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2033447 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01876
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE REPORTER, THE PT'S MOTHER, REPORTED THAT ON (B)(6) 2011 THE PT OBTAINED A LOUD VIBRATING ALARM ON THE PUMP; PRIOR TO THIS ALARM THE PUMP SELF-REBOOTED. THE PT OBSERVED THE PUMP REBOOT, AND HAD NO HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PT DID NOT REPORT ANY SYMPTOMS AND DENIED SEEKING MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THERE WERE NO CRACKS OR CORROSION IN THE BATTERY COMPARTMENT, NO DAMAGE TO THE BATTERY CAP, THE THREADS AND O-RING WERE SECURE, AND THE BATTERY CAP WAS TIGHT AND SECURE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR