BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2071253 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02947
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. ALL KEYPAD BUTTONS WERE RESPONDING INTERMITTENTLY. THE KEYPAD WAS REMOVED AND ADHESIVE WAS FOUND UNDER THE CONTACTS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PATIENT CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PATIENT CLAIMED THAT THE PUMP WAS INTERMITTENTLY UNRESPONSIVE TO UP ARROW BUTTON PRESSES. THE PATIENT DENIED THAT THE PUMP WAS EXPOSED TO MOISTURE. HE INDICATED THAT THE KEYPAD WAS INTACT. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE PUMP WAS NOT RESPONDING APPROPRIATELY TO KEYPAD BUTTON PRESSES. THERE IS NO EVIDENCE HOWEVER THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE.

    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 52