BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3863603 · Received June 10, 2014

    Report

    Report Number
    2531779-2014-16273
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    June 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS FOUND TO BE TORN AT THE OK BUTTON. EVALUATION REVEALED THAT ALL OF THE KEYPAD BUTTONS WERE RESPONDING PROPERLY. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER ALL OF THE KEY CONTACTS. UNRELATED TO THIS COMPLAINT, MOISTURE WAS EVIDENT BEHIND THE DISPLAY LENS. A LEAK TEST SHOWED A LEAK AT THE KEYPAD COVER TEAR. THE PUMP COVER WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS OBSERVED ON INTERNAL COMPONENTS. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (DAMAGE PRIOR TO TACTILE CHANGE) ISSUE. IT WAS REPORTED THAT THE KEYPAD WAS TORN, AND ALL THE KEYPAD BUTTONS WERE UNRESPONSIVE. 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
    338091 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR