BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2923680 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-00896
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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: EVALUATION REVEALED THAT ALL OF THE BUTTON SYMBOLS WERE WORN BUT THE KEYPAD WAS INTACT. THE CONTRAST, UP AND DOWN KEYS RESPONDED APPROPRIATELY AND THE OK KEY WAS INTERMITTENTLY UNRESPONSIVE. EVALUATION REVEALED THERE WAS CONTAMINATION UNDER ALL BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE PUMP BOOTED TO THE VERIFY SCREEN WITH A DIM, PINK CONTRAST AND A SCRATCHED DISPLAY LENS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE OK BUTTON WAS INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE HARD PRESSES TO ELICIT A RESPONSE. THE REPORTER DENIED GETTING THE PUMP WET AND THERE WAS NO TRAUMA TO THE PUMP. THE REPORTER CONFIRMED THAT THE KEYPAD WAS INTACT. THE PATIENT REPORTEDLY WORE THE PUMP ATTACHED TO A BELT AND DOES NOT CLEAN THE PUMP. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS BEING MADE DUE TO THE KEYPAD RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29008 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR