BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1942359 · Received December 22, 2010

    Report

    Report Number
    2531779-2010-03069
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 24, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED THAT THE FORCE SENSOR WAS VISIBLY DAMAGED. AN "EZPRIME" OPERATION WAS PERFORMED AND THE PUMP DISPENSED FLUID FROM THE CARTRIDGE DURING THE LOAD STEP AND EMITTED A "NO CARTRIDGE DETECTED" WARNING. REVIEW OF THE PUMP HISTORY DID NOT REVEAL ANY LOSS OF PRIME WARNINGS ASSOCIATED WITH DISCREPANT FORCE.

    Description of Event or Problem · 1

    EVAL REVEALED THAT THE FORCE SENSOR WAS VISIBLY DAMAGED.

    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 69 YR