BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1821776 · Received August 26, 2010

    Report

    Report Number
    2531779-2010-01093
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. A REVIEW OF THE PUMP HISTORY INDICATED THAT A "LOSS OF CARTRIDGE DETECTION" HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING. DURING EVAL, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AND MOISTURE WAS OBSERVED INSIDE THE PUMP. THE FORCE SENSOR SOCKET AND PINS WERE FOUND TO EXHIBIT VISIBLE MOISTURE DAMAGE. THE PUMP USER GUIDE INSTRUCTS THE USER TO INSPECT THE PUMP AND CONFIRM THAT IT IS OPERATING PROPERLY. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DISPENSED INSULIN DURING THE LOAD CARTRIDGE PHASE AND DISPLAYED THE MESSAGE "NO CARTRIDGE DETECTED." PT WAS NOT CONNECTED TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR