BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3943433 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20573
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 - DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/12/2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH NO VISIBLE DAMAGE TO THE KEYPAD COVER. DURING TESTING, ALL OF THE KEYPAD BUTTONS WERE NORMALLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION AS FOUND UNDER ANY OF THE KEYPAD BUTTON CONTACTS. THERE WAS CORROSION OBSERVED INSIDE THE BATTERY COMPARTMENT. THE LEAK TEST FAILED DUE TO A DISPLAY LENS LEAK. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS OBSERVED ON INTERNAL COMPONENTS OF THE PUMP.

    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 BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT ALL THE KEYPAD BUTTONS WERE UNDER-RESPONSIVE, AND THAT THERE WAS EVIDENCE OF MOISTURE IN THE BATTERY COMPARTMENT. 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
    422618 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR