BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2072963 · Received April 13, 2011

    Report

    Report Number
    2531779-2011-02750
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 26, 2011
    Report Date
    March 26, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PT REPORTED THAT THE OK KEYPAD BUTTON HAS REQUIRED MULTIPLE PRESSES TO OBTAIN A RESPONSE OVER THE PAST MONTH. SHE STATED THAT HER BOLUSES HAVE BEEN CANCELLED WITHOUT USER INTERVENTION ON 2 SEPARATE OCCASIONS. THE PT STATED THAT ON BOTH OCCASIONS SHE NOTICED RIGHT AWAY AND DID NOT EXPERIENCE ANY BLOOD GLUCOSE EXCURSIONS. SHE NOTED THAT THE OK KEYPAD BUTTON DOES NOT CLICK AND SPRING BACK WHEN PRESSED. THE PT CONFIRMED THAT THE KEYPAD IS INTACT; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT SHE WEARS THE PUMP IN HER BRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR