BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4911161 · Received July 13, 2015

    Report

    Report Number
    2531779-2015-23528
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Report Date
    June 25, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/26/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/06/2015 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH MOISTURE IN THE BATTERY COMPARTMENT. LEAK TEST FAILED DUE TO A CRACK ALONGSIDE THE BATTERY COMPARTMENT. OPENED PUMP- MOISTURE OBSERVED ON THE SUPPORT BRACKET. ALL OF THE KEYPAD BUTTONS RESPOND PROPERLY. NO PHYSICAL DAMAGE ON KEYPAD. REMOVED KEYPAD- NO CONTAMINATION OBSERVED. AUDIO BOLUS BUTTON IS TORN- STILL OPERABLE. RETURNED BATTERY CAP USED FOR TESTING.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451887 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR