BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2142248 · Received June 28, 2011

    Report

    Report Number
    2531779-2011-04524
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE WORN BUT INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION CONFIRMED THAT THE OK AND DOWN ARROW KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THE BUTTONS DO NOT CLICK AND SPRING BACK NORMALLY. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE DOWN ARROW AND OK KEYPAD BUTTON HAVE NOT BEEN RESPONDING PROPERLY FOR THE PAST WEEK. SHE STATED THAT THE PATIENT WEARS THE PUMP IN A CASE ATTACHED TO HIS BELT, AND DENIED CLEANING THE PUMP WITH ANYTHING.

    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 63 YR