BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1881618 · Received October 20, 2010

    Report

    Report Number
    2531779-2010-01742
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 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
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. A PREVIOUSLY UNREPORTED PUMP CASE CRACK AT THE DISPLAY LENS SITE WAS OBSERVED; TESTING REVEALED A LEAK THROUGH THE CRACK. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. EVIDENCE OF MOISTURE WAS OBSERVED ON THE BATTERY TERMINALS, FORCE SENSOR PLATE, MOTOR FLEX CONNECTOR, AND SOCKETS. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP EMITTED LOSS OF PRIME WARNINGS MULTIPLE TIMES AFTER THE PUMP WAS EXPOSED TO WATER. A FAMILY MEMBER STATED THAT AFTER EACH WARNING THE PATIENT WAS DISCONNECTED FROM THE INFUSION SITE, THE PUMP WAS PRIMED, AND ANOTHER LOSS OF PRIME WARNING OCCURRED IMMEDIATELY. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR