BEUDAMED
    FDA Adverse Event Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3970364 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21913
    Date Received
    July 31, 2014
    Report Date
    July 26, 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. 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/25/2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH VISIBLE EVIDENCE OF MOISTURE BEHIND THE DISPLAY LENS. DUE TO INTERNAL MOISTURE DAMAGE, THE PUMP WAS UNRESPONSIVE WITH THE RETURNED BATTERY CAP AND TEST BATTERY CAP. THE PUMP HAD A BLANK DISPLAY WITH NO AUDITORY OR VIBRATORY FEATURES. THE LEAK TEST FAILED DUE TO A DISPLAY LENS LEAK. THE PUMP WAS OPENED AND MOISTURE WAS FOUND INSIDE THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THE REPORTER ALLEGED THAT THERE WAS EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN AND AT THE KEYPAD. 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
    447426 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR