BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3122450 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06810
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 08/19/2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS FOUND TO BE DAMAGED AROUND THE OK BUTTON. DURING TESTING, THE OK BUTTON WAS FOUND TO BE INTERMITTENTLY UNRESPONSIVE; ALL OTHER KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS PRESENT UNDER ALL KEY CONTACT; THE OK BUTTON CONTACT WAS FOUND TO BE INVERTED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE CARTRIDGE COMPARTMENT WAS DAMAGED. THE CARTRIDGE CAP WAS ABLE TO FIT SECURELY AND MAINTAINED PRIME. 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 BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE) ISSUE. THE REPORTER INDICATED THAT THE UP, DOWN, AND OK BUTTONS WERE INTERMITTENTLY RESPONDING. THE REPORTER INDICATED THAT THE KEYPAD WAS TORN BUT THE RESPONSE CHANGE OCCURRED PRIOR TO THE KEYPAD DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224641 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR