BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3760470 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10660
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    April 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/12/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/09/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT OF AN UNRESPONSIVE AUDIO BOLUS BUTTON WAS NOT DUPLICATED DURING TESTING. THE AUDIO BOLUS BUTTON WAS FOUND TO BE INTACT AND RESPONDED APPROPRIATELY. EVALUATION REVEALED MOISTURE UNDER THE DISPLAY. THE DISPLAY LENS WAS OBSERVED TO BE CRACKED. A LEAK TEST WAS PERFORMED AND A DISPLAY LENS LEAK WAS FOUND. THE PUMP WAS OPENED AND ADDITIONAL MOISTURE WAS FOUND ON THE PRINTED CIRCUIT BOARD. 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (ABB TACTILE CHANGES W/MOISTURE) ISSUE. IT WAS REPORTED THAT AUDIO BOLUS BUTTON WAS UNRESPONSIVE. THE REPORTER STATED THAT THERE WAS MOISTURE BEHIND THE DISPLAY. 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
    240727 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR