BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1870283 · Received October 6, 2010

    Report

    Report Number
    2531779-2010-01484
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 7, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND FOUND TO HAVE ALL KEYPAD BUTTONS INTERMITTENTLY RESPONDING. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER BUTTON CONTACTS. CONTAMINATION WAS OBSERVED UNDER BUTTONS DURING INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT ALLEGED THAT THE BUTTONS HAD TO BE PRESSED SEVERAL TIMES BEFORE THE PUMP WOULD RESPOND.

    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
    1 109 YR