BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1874144 · Received October 15, 2010

    Report

    Report Number
    2531779-2010-01697
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE BATTERY COMPARTMENT WAS CRACKED AND THE PUMP WAS INTERMITTENTLY RESPONDING TO THE AUDIO BOLUS BUTTON. THERE WAS ALSO ADHESIVE (CONTAMINATION) FOUND ON THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PUMP IS REPORTEDLY NOT RESPONDING WHEN THE AUDIO BOLUS BUTTON IS PRESSED; HOWEVER, THE OTHER BUTTONS ARE WORKING FINE. THE PT INDICATED THAT THE KEYPAD IS NOT PEELING AND THE PUMP HAS NOT GOTTEN WET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1