BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3081284 · Received April 26, 2013

    Report

    Report Number
    2531779-2013-05402
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/10/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/11/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD WAS FULLY INTACT BUT THE KEYPAD SYMBOLS WERE WORN. EVALUATION REVEALED THAT ALL OF THE KEYPAD BUTTONS RESPONDED APPROPRIATELY. INVESTIGATORS REMOVED KEYPAD COVER TO CHECK CONDITION OF THE BUTTON CONTACTS. UNDER MAGNIFICATION, OBSERVED CONTAMINATION FORMING ON ALL BUTTON CONTACTS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON 05/24/2013 WITH THE FOLLOWING FINDINGS. 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

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THAT FOR APPROXIMATELY ONE YEAR, THE UP, DOWN AND OKAY BUTTONS HAVE BEEN DIFFICULT TO PRESS. 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
    182488 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR