BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1812913 · Received August 16, 2010

    Report

    Report Number
    2531779-2010-01002
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 DISCOVERED THAT THE FORCE SENSOR RESISTANCE READING WAS OUT OF CALIBRATION. DURING EVAL, THE PUMP DISPENSED INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP.

    Description of Event or Problem · 1

    EVAL REVEALED THAT THE FORCE SENSOR RESISTANCE MEASUREMENT WAS OUT OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1