BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2925593 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-01039
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 10, 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. 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).

    Additional Manufacturer Narrative · 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 RETURNED PEELING AT THE OK BUTTON. A DAMAGED KEYPAD WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTONS WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE DAMAGED KEYPAD SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP. DURING TESTING, THE OK, UP ARROW, AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED/FADED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. 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
    29570 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1