BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2130332 · Received June 16, 2011

    Report

    Report Number
    2531779-2011-04228
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. THE PUMP WAS INTERMITTENTLY UNRESPONSIVE TO ALL KEYPAD BUTTON PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS FOUND UNDER THE BUTTON CONTACTS. THE BATTERY COMPARTMENT WAS ALSO FOUND TO BE CRACKED. THE REPORTED CRACKED BATTERY COMPARTMENT ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE ISSUE IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER AND BECAUSE THE ISSUE DOES NOT AFFECT THE PUMP'S INSULIN DELIVERY FUNCTIONS. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PATIENT CLAIMED THAT THE PUMP WAS INTERMITTENTLY UNRESPONSIVE TO OK BUTTON PRESSES. 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 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR