BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2063204 · Received April 12, 2011

    Report

    Report Number
    2531779-2011-02492
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION CONFIRMED THAT THE UP ARROW KEYPAD BUTTON REQUIRES MULTIPLE PRESSES TO OBTAIN A RESPONSE. IT WAS OBSERVED THAT ALL BUTTON KEY CONTACTS SPRING BACK WHEN PRESSED. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL BUTTON KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PATIENT REPORTED THAT THE UP ARROW KEYPAD BUTTON HAS BEEN INTERMITTENTLY UNRESPONSIVE FOR A FEW WEEKS. SHE CONFIRMED THAT THE RUBBER KEYPAD IS INTACT; DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS; AND STATED THAT SHE WEARS THE PUMP IN HER POCKET, IN HER BRA, OR ON HER WAISTBAND.

    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 71 YR