BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1760203 · Received July 12, 2010

    Report

    Report Number
    2531779-2010-00517
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY CAP CONTACT HEIGHT WAS OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    EVAL REVEALED THE BATTERY CONTACT HEIGHT WAS OUTSIDE SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1