BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3190394 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09010
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 08/26/2013, ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. DEVICE EVALUATION: ON EXAMINATION, THE AUDIO BOLUS BUTTON WAS NOTED TO BE DETACHED FROM THE PUMP. TESTING OF THE AUDIO BOLUS BUTTON WAS NOT POSSIBLE DUE TO THE BUTTON COVER BEING DETACHED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ALLEGING THE AUDIO BOLUS BUTTON ON THE PUMP WAS UNRESPONSIVE. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE AUDIO BOLUS BUTTON MALFUNCTION REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290815 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1