BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3852512 · Received June 5, 2014

    Report

    Report Number
    2531779-2014-15978
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    June 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/30/2014 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/25/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION CONFIRMED THAT THERE WAS MOISTURE BEHIND THE DISPLAY LENS. DURING TESTING, THE PUMP POWERED ON WITH AUDIO TONES AND VIBRATIONS USING THE RETURNED BATTERY CAP. THE KEYPAD COVER WAS INTACT; NO DAMAGE WAS OBSERVED. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION WAS FOUND UNDER ANY BUTTON CONTACTS. A LEAK TEST WAS PERFORMED AND A DISPLAY LENS LEAK WAS FOUND. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS BLANK. THE COMPLAINT OF THE UNDER RESPONSIVE KEYPAD BUTTONS WAS NOT ABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE BLANK DISPLAY AND MOISTURE DAMAGE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT ALL KEYPAD BUTTONS WERE UNDER RESPONSIVE. IT WAS NOTED 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
    328810 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR