BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2141913 · Received June 28, 2011

    Report

    Report Number
    2531779-2011-04513
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    May 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO CONCLUSIONS 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: THE KEYPAD WAS OBSERVED TO BE TORN BETWEEN THE CONTRAST BUTTON AND THE UP ARROW BUTTON. THE DISPLAY SCREEN WAS OBSERVED TO HAVE MOISTURE BEHIND THE LENS. THE PUMP BOOTED WITH AUDIBLE TONES. THE KEYPAD WAS UNABLE TO BE CONFIRMED TO BE WORKING DUE TO THE UNRELATED ISSUE THAT THE DISPLAY NOT BEING OPERATIONAL.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT THE KEYPAD BUTTONS ON THE PATIENT'S PUMP STOPPED ACTIVATING DESIRED PUMP FUNCTIONS WHEN PRESSED. SHE SAID THE PUMP WAS CANCELING BOLUS DOSES, NOT RESPONDING TO BUTTON PRESSES, OR RESPONDING SLOWLY AFTER PRESSING THE BUTTONS. THERE WAS NO EVIDENCE OF MISUSE OF THE PRODUCT. THE PATIENT REPORTEDLY DOES NOT CLEAN THE PUMP. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.

    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 8 YR