BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2121263 · Received June 13, 2011

    Report

    Report Number
    2531779-2011-04082
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE PRODUCT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT WHILE AT DOCTOR'S OFFICE, THE DOCTOR HAD DIFFICULTY GETTING THE KEYPAD TO RESPOND. THE KEYPAD BUTTONS REPORTEDLY REQUIRED MULTIPLE HARD PRESSES FOR A RESPONSE. PATIENT DID NOT CLEAN PUMP. PATIENT WORE THE PUMP IN A POCKET.

    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 17 YR