BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2981462 · Received February 27, 2013

    Report

    Report Number
    2531779-2013-02228
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 04/23/2012 DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THE KEYPAD IS DAMAGED; THE KEYPAD COVER HAS BEEN TORN OFF AT THE OK BUTTON WITH THE BUTTON CONTACT EXPOSED. A DAMAGED KEYPAD RUBBER WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTONS WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE DAMAGED KEYPAD RUBBER SHOULD BE CLEARLY VISIBLE AND PROHIBIT THE USE OF THE KEYPAD BUTTONS. USERS MAY EXPECT KEYPAD DAMAGE DURING NORMAL WEAR AND THE OWNER'S BOOKLET INSTRUCTS THE USER TO CONTACT CUSTOMER SERVICE IF THE USER SUSPECTS THE PUMP MAY BE DAMAGED. ON TESTING, ALL THE KEYPAD BUTTONS DEMONSTRATED INTERMITTENT RESPONSE AND REQUIRED MULTIPLE PRESSES WITH INCREASING FORCE TO EVOKE A RESPONSE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE BUTTONS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    DATE OF SUBMISSION OF FOLLOW UP #1 IS (B)(4) 2013. DATE OF ADDITIONAL ANALYSIS IN FOLLOW UP #1 IS (B)(4) 2013.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE) ISSUE. IT WAS REPORTED THAT ALL OF THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE BUTTON PRESSES TO ELICIT A RESPONSE. REPORTEDLY, THE RUBBER KEYPAD WAS PEELING UP BELOW THE OK BUTTON AND THE TACTILE CHANGES HAD OCCURRED PRIOR TO THE KEYPAD DAMAGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84442 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR