BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2070139 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02908
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. INSPECTION REVEALED THAT THE KEYPAD IS PEELING AT THE OK KEYPAD BUTTON. EVALUATION CONFIRMED THAT THE DOWN ARROW KEYPAD BUTTON IS INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL BUTTON KEY CONTACTS. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PATIENT REPORTED THAT THE DOWN ARROW KEYPAD BUTTON IS STICKING AND REQUIRES MULTIPLE PRESSES TO OBTAIN A RESPONSE. SHE NOTED THAT THE DOWN ARROW BUTTON CLICKS INTERMITTENTLY WHEN PRESSED. THE PATIENT STATED THAT THE DOWN ARROW BUTTON BECAME INTERMITTENTLY UNRESPONSIVE A WEEK AGO, AND TODAY THE KEYPAD BEGAN PEELING. SHE CONFIRMED THAT ALL OTHER KEYPAD BUTTONS ARE RESPONDING APPROPRIATELY AND CLICK BACK AS EXPECTED. THE PATIENT DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR