BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2140878 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04484
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE OK BUTTON WAS FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND THE BUTTON CONTACT WAS FOUND TO BE INVERTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE OK BUTTON HAD A DELAYED RESPONSE AND LOOKED "DEFLATED". THE PATIENT REPORTEDLY WORE THE PUMP ON THE OUTSIDE OF CLOTHING AND DID NOT CLEAN 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 16 YR