BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3071468 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04798
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE KEYPAD WAS NOTED TO BE TORN AND PEELING BELOW THE OK BUTTON. 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 HAD INTERMITTENT RESPONSE AND REQUIRED MULTIPLE PRESSED TO EVOKE A RESPONSE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE BUTTONS.

    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 THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND THE BOTTOM OF THE KEYPAD HAS LIFTED UP AND HAS A TEAR IN IT. IT WAS CONFIRMED TACTILE CHANGES FIRST AND THEN 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
    172647 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR