BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2181795 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05374
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 UP AND CONTRAST BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE CONTRAST BUTTON HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER ALL OF THE BUTTON CONTACTS.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE DOWN ARROW KEYPAD BUTTON IS INTERMITTENTLY UNRESPONSIVE. SHE CONFIRMED THAT THE KEYPAD IS INTACT. SHE STATED THAT THE PATIENT WEARS THE PUMP IN A PUMP SKIN, AND DOES NOT CLEAN THE PUMP.

    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 14 YR