BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3192430 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09075
    Event Type
    Malfunction
    Date Received
    June 27, 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
    MA, US
    Reporter Occupation
    OTHER

    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

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, VISIBLE MOISTURE WAS OBSERVED IN THE DISPLAY SCREEN. THE PUMP WAS NOT ABLE TO BE POWERED ON. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE PUMP CASE WAS CRACKED ON THE UPPER RIGHT SIDE AND THE PUMP FAILED THE LEAK TEST. THE PUMP WAS OPENED AND REVEALED MOISTURE OR CORROSION ON ALL INTERNAL SURFACES OF THE PUMP. ALSO UNRELATED TO THE COMPLAINT, FURTHER TESTING WAS NOT PERFORMED DUE TO THE KEYPAD BUTTONS NOT BEING FUNCTIONAL. 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.

    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 THE DISPLAY SCREEN WAS BLANK AFTER A RECENT BATTERY CHANGE. THE REPORTER NOTED THAT THE PUMP HAD BEEN EXPOSED TO WATER BEFORE THE BATTERY CHANGE. 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
    292754 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR