BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2191732 · Received August 4, 2011

    Report

    Report Number
    2531779-2011-05611
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    May 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. DURING EVALUATION THE PUMP DISPENSED INSULIN DURING THE LOAD CARTRIDGE PHASE. (B)(6). CORRECTION NUMBER - 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE REPORTED THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT'S WIFE ALSO REPORTED THAT THE LOAD STEP DURING THE EZPRIME PROCESS WAS NOT FUNCTIONING AND WAS CAUSING A LARGER THAN NORMAL PRIME VOLUME. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION AND THE FORCE SENSOR PINS WERE PARTIALLY DISLODGED. THIS REPORT IS BEING MADE BASED ON THE INVESTIGATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR