BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3102164 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06077
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/09/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD WAS TORN OVER THE UP BUTTON AND THE KEYPAD SYMBOLS WERE FOUND TO BE WORN. ALL BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. EVALUATION REVEALED THAT THERE WAS CONTAMINATION UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND PINK AND DISPLAY LENS WAS SCRATCHED. A LEAK TEST WAS PERFORMED AND A LEAK IS FOUND FROM DISPLAY LENS. AND THERE WAS INTERNAL MOISTURE FOUND IN THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. IT WAS REPORTED THAT ALL OF THE KEYPAD BUTTONS WERE UNRESPONSIVE POTENTIALLY DUE TO MOISTURE IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203840 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1