BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2170533 · Received July 21, 2011

    Report

    Report Number
    2531779-2011-05083
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: THERE WERE NO SIGNS OF DAMAGE TO THE KEYPAD. THE KEYPAD BUTTONS WERE FOUND TO BE UNRESPONSIVE TO PRESSES. THE KEYPAD WAS REMOVED AND NO DEFECTS WERE FOUND TO THE BUTTON CONTACTS. THE PUMP WAS OPENED AND THE BOLUS BUTTON SOLDER CONTACTS WERE SHORTED TO THE BUTTON HOUSING DUE TO EXCESS SOLDER.

    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

    A FAMILY MEMBER REPORTED THAT WHILE TRYING TO GIVE INSULIN, THE METER STATED THAT A BUTTON WAS PUSHED TO CANCEL THE BOLUS. THE FAMILY MEMBER REPORTEDLY TOOK THE BATTERY OUT OF THE PUMP AND THEN KEYPAD BUTTONS DID NOT RESPOND AT ALL. THE FAMILY MEMBER CONFIRMED THAT THE KEYPAD WAS INTACT AND THE BUTTONS WERE SPRINGING BACK NORMALLY. THE PATIENT REPORTEDLY WORE THE PUMP IN A PUMP SKIN AND DID 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 11 YR