BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2192149 · Received August 4, 2011

    Report

    Report Number
    2531779-2011-05622
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 5, 2011
    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

    (B)(4). 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 REVEALED THAT ALL KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS. INSPECTION REVEALED THAT THE BOLUS BUTTON HAS A HOLE IN IT AND IS INOPERABLE. INSULIN CAN BE DELIVERED USING THE NORMAL BOLUS FEATURE. THIS DEFECT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    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

    IT WAS REPORTED THAT ALL KEYPAD BUTTONS (UP ARROW, DOWN ARROW, OKAY, AND CONTRAST) WERE UNRESPONSIVE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE ABOUT THIS COMPLAINT. THE COMPLAINT IS BEING REPORTED BECAUSE UNRESPONSIVE BUTTONS HAVE BEEN KNOWN ON OCCASION TO CONTRIBUTE TO A PATIENT EVENT.

    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