BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1872569 · Received October 8, 2010

    Report

    Report Number
    2531779-2010-01537
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED A MISALIGNED DISPLAY SCREEN AND DISLODGED FORCE SENSOR PINS. REVIEW OF THE PUMP HISTORY REVEALED LOSS OF PRIME WARNINGS ASSOCIATED WITH ZERO FORCE AND "NO CARTRIDGE DETECTED" WARNINGS. DURING EVAL A LOAD CARTRIDGE STEP WAS PERFORMED AND THE PUMP DID NOT DETECT THE CARTRIDGE, DISPENSED FLUID FROM THE CARTRIDGE, AND EMITTED A "NO CARTRIDGE DETECTED" WARNING.

    Description of Event or Problem · 1

    THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE DISTRIBUTOR REPORTED THAT THE PUMP DISPENSED INSULIN FROM THE CARTRIDGE DURING AN "EZPRIME" OPERATION.

    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