BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2031455 · Received March 17, 2011

    Report

    Report Number
    2531779-2011-01763
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED CONTAMINATION UNDER BUTTON CONTACTS. THE OK BUTTON CONTACT WAS MISALIGNED. THE OK BUTTON DID NOT ACTIVATE DESIRED PUMP FUNCTIONS WHEN PRESSED. THE DOWN ARROW BUTTON INTERMITTENTLY ACTIVATED DESIRED PUMP FUNCTIONS. THE OK BUTTON DID NOT SPRING BACK WHEN PRESSED.

    Description of Event or Problem · 1

    THE PT STATED THAT THE OK BUTTON DOES NOT ACTIVATE DESIRED PUMP FUNCTIONS WHEN PRESSED. THE PUMP WAS NOT EXPOSED TO ANY WATER OR CLEANING PRODUCTS. SHE SAID THE OK BUTTON ALSO FELT FLAT. NO OTHER BUTTONS REPORTEDLY RESPOND TO BUTTON PRESSES.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR