BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2091667 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03467
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    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 PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND BUTTON CONTACTS WERE FOUND TO BE MISALIGNED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE OK KEYPAD BUTTON IS UNRESPONSIVE. HE NOTED THAT THE OK BUTTON WAS RESPONDING APPROPRIATELY THE MORNING OF THE INCIDENT WHEN HE GAVE A NORMAL BOLUS FOR BREAKFAST, BUT NOW, THE BUTTON IS UNRESPONSIVE WHILE ATTEMPTING TO BOLUS FOR LUNCH. THE PATIENT STATED THAT THE OK KEYPAD BUTTON DOES NOT CLICK AND SPRING BACK WHEN PRESSED, AND THAT THE BUTTON SEEMS TO BE STUCK IN THE DOWN POSITION. HE ALSO REPORTED THAT THE DOWN ARROW KEYPAD BUTTON IS OVERLY RESPONSIVE; WHILE ATTEMPTING TO REWIND THE PUMP, HE NOTED THAT PRESSES OF THE DOWN ARROW KEYPAD BUTTON CAUSED SCROLLING THROUGH VARIOUS SCREENS. THE PATIENT STATED THAT HE REMOVED THE BATTERY WITH NO CHANGE IN BUTTON RESPONSIVENESS. HE STATED THAT HE WEARS THE PUMP ATTACHED TO HIS BELT, AND REPORTED THAT THE PUMP IS NOT EXPOSED TO CLEANING PRODUCTS.

    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 39 YR