BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2070818 · Received April 15, 2011

    Report

    Report Number
    2531779-2011-02610
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Report Date
    March 19, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS RECEIVED THE PUMP INVOLVED WITH THIS COMPLAINT AND PERFORMED DEVICE EVALUATION. THE "EZPRIME" PROCESS WAS PERFORMED AND DURING THE "LOAD" STEP, THE PUMP DID NOT RECOGNIZE THE CARTRIDGE AND PUSHED OUT ALL THE FLUID AND A "NO CARTRIDGE DETECTED" WARNING APPEARED. EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN AND DISLODGED FORCE SENSOR PINS AND THE FORCE SENSOR RESISTANCE MEASUREMENT WAS OUT OF CALIBRATION. THERE WAS ALSO A CRACKED AND MOISTURE DAMAGE WITH THE BATTERY COMPARTMENT OBSERVED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS DISPENSING ALL OF THE INSULIN (100 UNITS) OUT OF THE CARTRIDGE DURING THE LOAD STEP OF THE PRIMING PROCESS. THE PRIMING PROCESS WAS REPEATED BY THE USER; HOWEVER, THE REPORTED ISSUE WAS NOT RESOLVED. THERE WERE NO REPORTS OF ANY INJURIES AS A RESULT OF THE REPORTED ISSUE. A REPLACEMENT PUMP WAS SENT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1