BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3072746 · Received April 23, 2013

    Report

    Report Number
    2531779-2013-04894
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 27, 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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 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 OK BUTTON AND WAS FOUND TO BE WORN. ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY. EVALUATION REVEALED THAT THERE WAS NO CONTAMINATION WAS FOUND UNDER CONTACTS. THE DISPLAY WAS FOUND TO BE DIM AND PINK AND SCRATCHED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE). THE REPORTER STATED THAT THE OK KEYPAD BUTTON WAS UNRESPONSIVE AND THE KEYPAD WAS DAMAGED. THE REPORTER COULD NOT CONFIRM WHETHER THE DAMAGE OR THE RESPONSE ISSUE HAD OCCURRED FIRST. 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
    173430 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1