BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2770057 · Received October 3, 2012

    Report

    Report Number
    2531779-2012-11679
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: THE KEYPAD RUBBER IS UNDAMAGED; ALL BUTTONS RESPOND NORMALLY TO PRESSES. THE KEYPAD WAS REMOVED FROM THE BASE AND CONTAMINATION FOUND TO "UP" AND "CONTRAST" KEY CONTACTS. UNRELATED TO THE COMPLAINT, HE PUMP BOOTED WITH A FADED DISPLAY, WHEN A TEST DISPLAY SCREEN WAS USED DURING INVESTIGATION, THE PUMP BOOTED WITH A FULLY ILLUMINATED AND CLEAR DISPLAY.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 AND STATED THAT THE OK KEYPAD BUTTON WAS INTERMITTENTLY UNRESPONSIVE. THE PATIENT DENIED DAMAGE TO THE KEYPAD. THE PATIENT REPORTEDLY WORE THE PUMP ATTACHED TO A BELT AND DID NOT CLEAN IT. THERE IS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD RESPONSE ISSUE.

    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 29 YR