BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3233473 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11269
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP DISPLAY SCREEN WAS FOUND TO BE FADED AND DISCOLORED. THE DISPLAY SCREEN WAS REPLACED WITH A TEST SCREEN AND THE DISPLAY RETURNED TO NORMAL. UNRELATED TO THE DISPLAY ISSUE, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE BATTERY CAP WAS SECURED AND THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER LOSS. THE USER GUIDE INSTRUCTS THE PATIENT 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 TO ANIMAS AND WAS INVESTIGATED BY PRODUCT ANALYSIS ON 06/19/2013. INVESTIGATION FOUND THAT THE DISPLAY SCREEN WAS FADED AND DISCOLORED. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333524 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR