BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3822427 · Received May 20, 2014

    Report

    Report Number
    2531779-2014-14311
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/19/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE PUMP POWERED UP TO THE VERIFY SCREEN WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. THE VERIFY SCREEN WAS CLEAR AND LEGIBLE. THE INVESTIGATION WAS UNABLE TO DUPLICATE THE REPORTED CLOUDY DISPLAY ISSUE. RELATED TO THE REPORTED ISSUE, IT WAS OBSERVED THAT THE DISPLAY LENS WAS HEAVILY SCRATCHED AND MAKING THE SCREEN DIFFICULT TO READ.

    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 DISPLAY (CLOUDY) ISSUE. REPORTEDLY, THE DISPLAY WAS CLOUDY SINCE ABOUT 5 MONTHS AGO, AND THE REPORTER HAS DIFFICULTY READING THE SCREEN. THE REPORTER STATED THAT THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP. 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
    300297 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR