BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2213115 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05936
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    SHOULD HAVE READ: "(B)(4) DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS:". THE PRODUCT WAS INVESTIGATED ON (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4): ALL OF THE KEYPAD BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY TO BUTTON PRESSES. THE KEYPAD WAS REMOVED AND NO BUTTON CONTACT ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY ACTIVATING DESIRED PUMP FUNCTIONS WHEN PRESSED. THE ISSUE APPEARED TO BE OCCURRING AFTER MULTIPLE BUTTONS. THE PATIENT REPORTEDLY CLEANS THE PUMP WITH AN ANTIBACTERIAL WIPE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR