BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2840704 · Received November 20, 2012

    Report

    Report Number
    2531779-2012-13805
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUBMITTED (B)(4) 2012 FOLLOW-UP # 1 THE PUMP WAS RETURNED TO ANIMAS AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: TESTING CONFIRMED INTERMITTENT RESPONSES FORM THE 'UP' AND 'CONTRAST' BUTTONS. THE KEYPAD WAS DAMAGED, EXPOSING THE BUTTON CONTACTS, AND WAS REMOVED FOR INVESTIGATION. CONTAMINATION WAS NOTED UNDER ALL 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. (B)(6).

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THAT THE UP DOWN AND OK BUTTONS ON THE KEYPAD WERE UNRESPONSIVE. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS THE ALLEGED KEYPAD ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    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