BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2172734 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05123
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP WAS RETURNED TO ANIMAS. EVALUATION DEMONSTRATED THAT ALL KEYPAD BUTTONS ACTIVATED DESIRED PUMP FUNCTIONS WHEN PRESSED HOWEVER, ADHESIVE WAS FOUND UNDER THE KEYPAD BUTTON CONTACTS. UNRELATED TO THE COMPLAINT A CS 064 ALARM WAS OBSERVED DURING THE LOAD CARTRIDGE STEP AND THE PISTON DID NOT MOVE DURING REWIND. THIS ISSUE IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER AND IS UNLIKELY TO CAUSE AN ADVERSE EVENT. ALSO UNRELATED TO THE ALLEGED ISSUE, THE PUMP RETURNED TO DEFAULT DATE AND TIME AFTER REBOOTING. THE PUMP DISPLAYS THE "VERIFY" SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET TO CONFIRM THE "VERIFY" SCREEN. THE ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE PATIENT'S DAUGHTER CALLED ANIMAS ALLEGING THAT THE KEYPAD BUTTONS WERE GETTING WORN OUT AND THE PATIENT BELIEVES THEY ARE GETTING HARDER TO PRESS. AT THE TIME OF THE CALL THE PATIENT WAS PRESSING THE PUMP BUTTONS AND BELIEVES THE UP AND DOWN ARROW BUTTONS WERE MORE DIFFICULT TO PRESS. THE PUMP REPORTEDLY DOES NOT GET CLEANED. THERE IS NO EVIDENCE OF MISUSE OF THE PRODUCT. THERE IS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 14 YR