BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2122877 · Received June 14, 2011

    Report

    Report Number
    2531779-2011-04113
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE WORN BUT INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT THE UP ARROW AND CONTRAST KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. A LEAK TEST WAS PERFORMED, AND THERE WAS NO LEAKING OBSERVED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE UP ARROW KEYPAD BUTTON REQUIRES MULTIPLE PRESSES TO OBTAIN A RESPONSE. HE STATED THAT ALL OTHER KEYPAD BUTTONS RESPOND APPROPRIATELY. HE CONFIRMED THAT THE RUBBER KEYPAD IS INTACT. THE PATIENT STATED THAT HE SWIMS WITH THE PUMP; NOTED THAT HE WEARS THE PUMP IN HIS POCKET; AND DENIED EXPOSING THE PUMP TO CLEANING PRODUCTS.

    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 29 YR