BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3140750 · Received May 31, 2013

    Report

    Report Number
    2531779-2013-07460
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Report Date
    May 7, 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 (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS PEELING AT THE OK BUTTON. DURING TESTING, THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE OK AND CONTRAST KEYPAD BUTTONS RESPONDED APPROPRIATELY. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. THE DISPLAY SCREEN WAS FOUND TO BE FADED; A TEST SCREEN WAS INSTALLED AND DISPLAYED APPROPRIATELY. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE) ISSUE. IT WAS REPORTED THAT THE UP ARROW KEYPAD BUTTON WAS UNRESPONSIVE AND THE KEYPAD WAS PEELING/TORN/WORN. IT COULD NOT BE DETERMINED IF THE TACTILE CHANGES OCCURRED PRIOR TO THE DAMAGE TO THE KEYPAD. 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
    241944 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1