BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2830053 · Received November 13, 2012

    Report

    Report Number
    2531779-2012-13496
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    FOLLOW UP #1 SUBMITTED: 12/14 /2012 DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THE KEYPAD WAS NOTED TO BE TORN OVER THE OK BUTTON. A DAMAGED KEYPAD 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 SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP. ON TESTING, THE DOWN ARROW AND OK BUTTONS DEMONSTRATED INTERMITTENT RESPONSE. THE REMAINDER OF THE BUTTONS HAD NORMAL RESPONSE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS AND THE CONTACTS OF THE UP ARROW, DOWN ARROW AND OK BUTTONS WERE NOTED TO BE INVERTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS, ALLEGING ALL THE KEYPAD BUTTONS WOULD STICK AND WERE INTERMITTENTLY UNRESPONSIVE. THE PATIENT NOTED CANCELED BOLUSES DUE TO THE BUTTONS STICKING. THE PATIENT NOTED A SLIT ON THE OK BUTTON, WHICH ALLEGEDLY OCCURRED AFTER THE TACTILE ISSUES. 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR