BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2233768 · Received September 3, 2011

    Report

    Report Number
    2531779-2011-06464
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE WAS ATTEMPTING TO PROGRAM A BOLUS, AND THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS ARE NOT RESPONDING APPROPRIATELY. HE STATED THAT THE UP ARROW IS INTERMITTENTLY RESPONSIVE, AND THE DOWN ARROW DOES NOT WORK AT ALL. THE PATIENT STATED THAT HE WEARS THE PUMP ON HIS BELT AND DOES NOT CLEAN THE PUMP.

    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 65 YR