BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3903853 · Received June 30, 2014

    Report

    Report Number
    2531779-2014-18628
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 08/06/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS OBSERVED TO BE CUT AND TORN. EVALUATION REVEALED THAT THE UP ARROW KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL OF THE KEY CONTACTS.

    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 (DAMAGE PRIOR TO TACTILE CHANGE) ISSUE. IT WAS REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE UNDER RESPONSIVE TO USER PRESSES. THE KEYPAD COVER WAS ALSO ALLEGEDLY DAMAGED. 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
    380117 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR