BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2192485 · Received August 5, 2011

    Report

    Report Number
    2531779-2011-05633
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE KEYPAD WAS TORN OVER THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS. 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. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS ARE UNRESPONSIVE. THERE WAS EVIDENCE OF CORROSION FOUND UNDER ALL KEY CONTACTS. A KEYPAD LEAK WAS FOUND DURING LEAK TESTING.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE SINCE THE PATIENT WORE THE PUMP IN THE POOL. SHE STATED THAT THE BUTTONS REQUIRE MULTIPLE PRESSES TO OBTAIN A RESPONSE. SHE STATED THAT THE PATIENT WEARS THE PUMP ON HIS BELT AND DOES NOT CLEAN THE PUMP.

    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 6 YR