BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2850241 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14043
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): THE KEYPAD WAS TORN NEXT TO THE UP AND DOWN ARROW KEYPAD BUTTONS. 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 INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES WITH INCREASED FORCE TO ENGAGE. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 STATING THAT THE KEYPAD BUTTONS REQUIRED MULTIPLE HARD PRESSES TO ELICIT A RESPONSE. THE PATIENT NOTED A CRACK BY THE ARROW KEYPAD BUTTONS AND ALLEGED THAT THE RESPONSE ISSUES HAD OCCURRED FIRST. THE PATIENT DENIED ANY EVIDENCE OF MOISTURE IN THE PUMP. THE PUMP WAS REPORTEDLY NOT CLEANED AND THE PATIENT REPORTEDLY WORE THE PUMP UNDER A GARMENT IN A CASE. THERE IS NO ADVERSE EVENT WITH THIS CASE. THIS CASE 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 15 YR