BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2851113 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14062
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 12, 2012
    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

    (B)(4): THERE IS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. 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. THE KEYPAD WAS FOUND TO BE PEELING NEAR THE OK KEYPAD BUTTON. A DAMAGED KEYPAD WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACTS NEGATIVELY IMPACTING THE BUTTON FUNCTION. THE DAMAGED KEYPAD IS OBVIOUS AND DETECTABLE AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE PUMP. DURING TESTING, ALL KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEYPAD CONTACTS.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 STATING THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE STICKING AND REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE. THE REPORTER DENIED ANY DAMAGE TO THE PUMP OR ANY EVIDENCE OF MOISTURE IN THE PUMP. THE PUMP WAS REPORTEDLY CLEANED WITH A DAMP CLOTH AND THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET. THERE IS NO ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD ISSUES.

    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