BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2090339 · Received May 16, 2011

    Report

    Report Number
    2531779-2011-03447
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED. ALL KEYPAD BUTTONS WERE RESPONDING INTERMITTENTLY. THE KEYPAD WAS REMOVED AND ADHESIVE WAS FOUND UNDER THE CONTACTS. THE CONTACTS WERE ALSO FOUND TO BE MISALIGNED. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CONTACTED AN ANIMAS ON BEHALF OF HER SON (THE PATIENT) ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE REPORTER CLAIMED THAT THE PUMP WAS INTERMITTENTLY RESPONSIVE TO OK BUTTON PRESSES. SHE CLAIMED THAT THE KEYPAD WAS INTACT. THE REPORTER DENIED THAT THE DEVICE WAS EXPOSED TO MOISTURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PUMP WAS NOT RESPONDING APPROPRIATELY TO KEYPAD BUTTON PRESSES. THERE IS NO EVIDENCE HOWEVER THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE.

    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 22