BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3300528 · Received August 21, 2013

    Report

    Report Number
    2531779-2013-13414
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Report Date
    July 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING FINDINGS: BATTERY COMPARTMENT CRACKED FROM THE THREADS TO THE PUMP CASE SEAL. THERE WERE INDICATIONS OF CORROSION INSIDE THE BATTERY COMPARTMENT. OPENED PUMP TO INSPECT FOR THE MOISTURE, NO EVIDENCE OF INTERNAL MOISTURE WAS FOUND. A DIM PINK DISPLAY SCREEN WAS FOUND. OPENED PUMP TO TAKE AWAY A BAD DISPLAY SCREEN TO PERFORM A TEST WITH A NEW GOOD DISPLAY SCREEN. THE GOOD DISPLAY SCREEN IS SHOWING A STRONG CONTRAST AND CLEAR TEXT.

    Description of Event or Problem · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A DIM PINK DISPLAY AND MOISTURE CORROSION IN THE BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON 07/25/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406727 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49