BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2090343 · Received May 16, 2011

    Report

    Report Number
    2531779-2011-03448
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. THE KEYPAD BUTTONS WERE RESPONDING INTERMITTENTLY. THE KEYPAD WAS REMOVED AND ADHESIVE WAS FOUND UNDER THE CONTACTS. MFR DATE: 05/03/2008.

    Description of Event or Problem · 1

    ON (B)(4) 2011, THE PATIENT CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PATIENT DENIED THAT THE DEVICE WAS EXPOSED TO WATER. SHE ALSO DENIED THAT THE KEYPAD WAS PEELING OR DAMAGED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER 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 DISTRIBUTOR 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 67