BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222425 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10403
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 09/13/2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; THERE WAS NO PEELING OR DAMAGE OBSERVED. THE COMPLAINT OF THE UNRESPONSIVE KEYPAD BUTTONS WAS NOT ABLE TO BE DUPLICATED; ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD COVER WAS REMOVED AND NO EVIDENCE OF CONTAMINATION WAS FOUND UNDER ANY KEY CONTACTS. DURING EVALUATION, MOISTURE WAS VISIBLE THROUGH THE DISPLAY LENS WHICH DISTORTED THE VIEW OF THE DISPLAY SCREEN. THERE WAS NO VISIBLE MOISTURE FOUND INSIDE THE BATTERY COMPARTMENT. THE PUMP COVER WAS REMOVED AND THERE WAS VISIBLE MOISTURE CORROSION ON THE PUMP¿S INTERNAL COMPONENTS AS WELL AS THE KEYPAD FLEX CONNECTOR. UNRELATED TO THE COMPLAINT, A DISPLAY LENS LEAK WAS FOUND. 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER STATED THAT THE KEYPAD BUTTONS WERE UNRESPONSIVE AFTER THE PUMP HAD BEEN EXPOSED TO WATER. THE REPORTER NOTED EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN. 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
    323533 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR