BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1983297 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00671
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. THE KEYPAD APPEARED TO BE INTACT WITH NO LIFTING OR PEELING OBSERVED. THE "UP/DOWN/OK/CONTRAST" KEYPAD BUTTONS WERE INTERMITTENTLY RESPONDING TO USER INPUTS AND REQUIRED EXCESSIVE FORCE TO ACTIVATE DURING TESTING. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION. THE "UP/DOWN/OK/CONTRAST" KEY CONTACTS WERE OBSERVED TO BE MISALIGNED. THE "UP/DOWN/OK" KEY CONTACTS WERE OBSERVED TO BECOME INVERTED WHEN PRESSED AND WERE NOT ALWAYS SPRINGING BACK. EVIDENCE OF KEYPAD ADHESIVE WAS FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PT CLAIMED THAT THE DOWN ARROW BUTTON REQUIRED SEVERAL PRESSES IN ORDER FOR THE PUMP TO RESPOND. SHE ALLEGED THAT THE OK BUTTON REQUIRED SEVERAL PRESSES IN ORDER FOR THE PUMP TO RESPOND. THE PT DENIED THAT THE KEYPAD WAS TORN/DAMAGED OR THAT THE PUMP WAS EXPOSED TO TRAUMA. SHE ALSO DENIED THAT THE DEVICE WAS EXPOSED TO WATER OR CLEANING AGENTS. THE PT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE.

    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