BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2161841 · Received July 14, 2011

    Report

    Report Number
    2531779-2011-04938
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 2531779-03/24/2010/003-R. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/14/2011. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT LARGE PRIME VOLUMES HAD OCCURRED WHICH WAS NOT DUPLICATED DURING TESTING. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR LARGE PRIME VOLUMES. EVALUATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION. THIS REPORT IS BEING MADE BASED ON RESULTS OF EVALUATION.

    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 54 YR