BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2150702 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04697
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE OK BUTTON PRESS DID NOT ACTIVATE DESIRED PUMP FUNCTION DURING TESTING. MULTIPLE BUTTON PRESSES ARE REQUIRED BEFORE THE BUTTON WILL ENGAGE. NONE OF THE BUTTONS HAVE NORMAL SPRING BACK OR CLICK. CONTAMINATION WAS OBSERVED UNDER THE CONTACTS OF ALL BUTTONS. UNRELATED TO THE COMPLAINT, DURING EVALUATION A CRACKED BATTERY COMPARTMENT WAS OBSERVED, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE OK BUTTON IS STICKING AND CANCELLING BOLUS.

    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 57 YR