BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191127 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09044
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, VISIBLE MOISTURE WAS OBSERVED IN THE DISPLAY SCREEN. THE DISPLAY WAS DIM AND UNREADABLE. THE KEYPAD BUTTONS WERE NOT ABLE TO BE TESTED DUE TO NO DISPLAY. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE CONTRAST BUTTON. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACK ON THE UPPER RIGHT CORNER OF THE PUMP CASE; THE PUMP FAILED THE LEAK TEST. THE PUMP WAS OPENED AND MOISTURE/CORROSION WAS FOUND ON ALL INTERNAL SURFACES. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER STATED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AFTER THE PUMP HAD BEEN EXPOSED TO WATER. THERE WAS 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
    291084 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR