BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2151783 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04714
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERE IS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. 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. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. MULTIPLE BUTTON PRESSES WERE REQUIRED BEFORE THE BUTTONS ENGAGE. DURING INVESTIGATION, EVIDENCE OF KEYPAD ADHESIVE WAS FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT AND A FAMILY MEMBER REPORTED A TWO MONTH HISTORY OF INTERMITTENT RESPONSIVENESS ON ALL BUTTONS ON THE KEYPAD. THEY STATED THAT THE BUTTONS STICK DOWN AND CONTINUE TO SCROLL OR THEY DO NOT RESPOND WHEN PRESSED. THE FAMILY DENIED DAMAGE TO THE RUBBER KEYPAD; THEY SAID IT WAS NOT PEELING. THEY NOTED THAT THE PUMP WAS NOT EXPOSED TO WATER; THE PATIENT WEARS THE PUMP IN A POCKET OR BRA; AND THE PUMP IS OCCASIONALLY CLEANED WITH WATER AND A SOFT CLOTH ON THE OUTSIDE OF THE PUMP. THE COMPLAINT IS BEING REPORTED BECAUSE UNRESPONSIVE BUTTONS HAVE BEEN KNOWN TO DELAY BOLUS DELIVERY IF THE PATIENT IS NOT PREPARED TO DELIVER INSULIN VIA AN ALTERNATIVE METHOD.

    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