BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3190938 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09033
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 09/12/2013. DEVICE EVALUATION: ON EXAMINATION, THERE WAS VISIBLE MOISTURE IN THE DISPLAY LENS. ON TESTING, THE PUMP FAILED TO POWER ON. INVESTIGATIONAL TESTING WAS NOT ABLE TO BE COMPLETED DUE TO NO POWER. A CRACK IN THE CASE NEAR THE TOP RIGHT CORNER OF THE DISPLAY SCREEN WAS NOTED. A LEAK TEST REVEALED MOISTURE LEAKAGE INTO THE PUMP AT THE SIGHT OF THE CRACK. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED MOISTURE CONTAMINATION INSIDE THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. THE REPORTER STATED THAT AFTER THE PUMP HAD POTENTIALLY BEEN EXPOSED TO WATER, THE DISPLAY SCREEN WAS BLANK AND HAD MOISTURE BEHIND IT. THE REPORTER CHANGED THE BATTERY AND THE SCREEN REMAINED BLANK. 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
    290290 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR