BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2002660 · Received February 8, 2011

    Report

    Report Number
    2531779-2011-00706
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 9, 2011
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. A BROKEN FORCE SENSOR PIN WAS ALSO OBSERVED. REVIEW OF THE PUMP DOWNLOAD HISTORY REVEALED LOSS OF PRIME WARNINGS ASSOCIATED WITH ZERO FORCE AND "NO CARTRIDGE DETECTED" WARNINGS. DURING THE LOAD STEP OF THE "EZPRIME" OPERATION, THE PUMP DISPENSED FLUID FROM THE CARTRIDGE AND EMITTED A "NO CARTRIDGE DETECTED" WARNING.

    Description of Event or Problem · 1

    THE PT STATED THE PUMP DISPENSED INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP. THE PT DENIED NOT REUSING CARTRIDGES AND STORES THEM AT ROOM TEMP. THERE WAS NO DUST/DEBRIS OBSERVED IN THE CARTRIDGE COMPARTMENT.

    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 42 YR