BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3200294 · Received July 1, 2013

    Report

    Report Number
    2531779-2013-09416
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DEVICE EVALUATION: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED NO RECORD OF LOSS OF PRIME. ON INVESTIGATION, A REWIND, LOAD AND PRIME SEQUENCE WAS SUCCESSFULLY PERFORMED WITHOUT LOSS OF PRIME. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT LOSS OF PRIME OCCURRING. THE FORCE SENSOR WAS FOUND TO BE OUT OF SPECIFICATION. THE PUMP WAS OPENED FOR INVESTIGATION. THERE WAS NO EVIDENCE OF DEFECT, DAMAGE OR CONTAMINATION OF THE PUMP¿S INTERIOR COMPONENTS.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013. FORCE SENSOR OUT OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298694 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1