BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3150160 · Received June 6, 2013

    Report

    Report Number
    2531779-2013-07845
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    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 WAS FOUND TO BE PEELING AT THE UP ARROW BUTTON. DURING TESTING, THE UP ARROW AND CONTRAST KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE; THE DOWN ARROW AND OK BUTTONS RESPONDED APPROPRIATELY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN. A TEST SCREEN WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY WITH NO SIGNS OF FADING OR DISCOLORATION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 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 IS PEELING AT THE UP BUTTON. A DAMAGED KEYPAD WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACTS NEGATIVELY IMPACTING THE BUTTON FUNCTION. THE DAMAGED KEYPAD IS OBVIOUS AND DETECTABLE AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE PUMP. THE CONTRAST AND UP BUTTONS RESPONDED INTERMITTENTLY AND THE OK AND DOWN BUTTONS RESPONDED APPROPRIATELY. THERE WAS CONTAMINATION UNDER ALL KEY CONTACTS. THE PUMP BOOTED TO THE VERIFY SCREEN WITH DIM PINK CONTRAST.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER 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
    250958 INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR