BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2230341 · Received September 1, 2011

    Report

    Report Number
    2531779-2011-06409
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: 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. THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE OK AND DOWN ARROW BUTTONS WERE FUNCTIONING INTERMITTENTLY. THE PATIENT REPORTED THAT WHILE ATTEMPTING TO PROGRAM A BOLUS, THE OK BUTTON WOULD NOT WORK. THE PATIENT CONFIRMED THAT THERE WAS NO TRAUMA TO THE PUMP, THE PUMP WAS NOT EXPOSED TO WATER, AND THE KEYPAD WAS INTACT. THE PATIENT REPORTEDLY WORE THE PUMP IN A PUMP CASE ATTACHED TO A BELT AND DID NOT CLEAN THE PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR