BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3233649 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11274
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: EVALUATION REVEALED THAT BATTERY COMPARTMENT CRACKED FROM THE THREADS TO THE PUMP CASE SEAL. THAT IS THE WAY THE MOISTURE PENETRATES TO BATTERY COMPARTMENT. INDICATE OF CORRODED INSIDE THE BATTERY COMPARTMENT WAS DUPLICATED. THERE WAS NO EVIDENCE OF INTERNAL MOISTURE. A DIM PINK DISPLAY SCREEN IS OBSERVED. OPEN 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. THE DISPLAY LENS WAS FOUND TO BE SCRATCHED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE KEYPAD WAS WORN. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE DISPLAY SCREEN IS DIM AND PINK AND FOUND TO BE SCRATCHED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334813 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR