BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2516875 · Received April 4, 2012

    Report

    Report Number
    2531779-2012-02786
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Report Date
    December 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/07/2012 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE BOLUS BUTTON WAS DIFFICULT TO PUSH, AND THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL BUTTON CONTACTS. UNRELATED TO THE BOLUS BUTTON ISSUE, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BOLUS BUTTON WAS DIFFICULT TO PUSH, AND THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL BUTTON CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 03/07/2012.

    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 21 YR