BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2140682 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04483
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE WORN BUT INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT THE CONTRAST KEYPAD BUTTON IS INTERMITTENTLY RESPONSIVE; ALL OTHER KEYPAD BUTTONS WERE FOUND TO RESPOND APPROPRIATELY TO PRESSES. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DOWN ARROW KEYPAD BUTTON BECAME INTERMITTENTLY UNRESPONSIVE A MONTH AGO. SHE STATED THAT THERE ARE NO HOLES OR TEARS IN THE KEYPAD; STATED THAT SHE WEARS THE PUMP IN HER POCKET; AND DENIED CLEANING THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR