BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1963963 · Received January 12, 2011

    Report

    Report Number
    2531779-2011-00196
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 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
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED THAT THE FORCE SENSOR PLATE WAS DIMPLED AND THAT THE FORCE SENSOR RESISTANCE READING WAS OUT OF CALIBRATION. REVIEW OF THE PUMP DOWNLOAD HISTORY REVEALED MULTIPLE "NO CARTRIDGE DETECTED" WARNINGS. AS "EZPRIME" OPERATION WAS PERFORMED AND DURING THE LOAD STEP THE PUMP DID NOT DETECT THE CARTRIDGE, DISPENSED FLUID, AND EMITTED A "NO CARTRIDGE DETECTED" WARNING.

    Description of Event or Problem · 1

    THE USER STATED THAT THE PUMP DISPENSED INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP. HE PT REWOUND AND LOADED THE PUMP AGAIN AND THE CARTRIDGE CONTINUED TO DISPENSE INSULIN ON THE LOAD STEP UNTIL A "NO CARTRIDGE DETECTED" ALARM WAS EMITTED.

    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 45 YR