BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2516202 · Received April 4, 2012

    Report

    Report Number
    2531779-2012-02777
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Date of Event
    December 19, 2012
    Report Date
    January 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 03/06/2012 WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR ASSEMBLY. DURING EVALUATION THE PUMP WAS ABLE TO REWIND, LOAD AND PRIME WITH NO ISSUES. UNRELATED TO THE EVENT THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. (B)(6). CORRECTION/REMOVAL REPORT NUMBER - 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 03/06/2012 WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR ASSEMBLY. THIS REPORT IS BEING MADE BASED ON THE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1200 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1