BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2030712 · Received March 22, 2011

    Report

    Report Number
    2531779-2011-01786
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. ALL KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS SPRING BACK AS EXPECTED WHEN PRESSED. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PT REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS HAVE BECOME INTERMITTENTLY UNRESPONSIVE OVER THE PAST SEVERAL WEEKS. HE NOTED THAT THE BUTTONS INTERMITTENTLY CLICK AND SPRING BACK AS EXPECTED. THE PT DENIED ANY PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO MOISTURE; AND STATED THAT HE WEARS THE PUMP IN HIS POCKET.

    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 24 YR