BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4912112 · Received July 14, 2015

    Report

    Report Number
    2531779-2015-23570
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Report Date
    June 23, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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. 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

    FOLLOW-UP #1: DATE OF SUBMISSION 09/07/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/11/2016 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THERE WAS VISIBLE MOISTURE BEHIND THE DISPLAY LENS. THE DISPLAY WAS BLANK. A LEAK TEST WAS PERFORMED AND FAILED DUE TO A KEYPAD LEAK. THE KEYPAD WAS REMOVED AND THERE WAS NO DAMAGE TO THE BUTTON CONTACTS OR THE KEYPAD FLEX CABLE. THE PUMP WAS OPENED AND THERE WAS MOISTURE CORROSION FOUND ON THE KEYPAD CONNECTOR, DISPLAY CONNECTOR AND OTHER AREAS OF THE PUMP. THERE WAS NO MOISTURE FOUND IN THE BATTERY COMPARTMENT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE UP, DOWN, AND OK BUTTONS WERE UNDER RESPONSIVE TO BUTTON PRESSES. THERE WAS NO INDICATION OF OVER OR UNDER DELIVERY RELATED TO THE BUTTON ISSUE. THE REPORTER INDICATED THAT THERE WAS NO NOTED DAMAGE TO THE KEYPAD. THE REPORTER INDICATED THAT THERE WAS MOISTURE INGRESS NOTED BEHIND THE DISPLAY SCREEN LENS. 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
    457156 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR