BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3171731 · Received June 16, 2013

    Report

    Report Number
    2531779-2013-08260
    Event Type
    Malfunction
    Date Received
    June 16, 2013
    Report Date
    May 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/10/2013 NOT 07/08/2013 AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/31/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/08/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT ALL OF THE BUTTONS SYMBOLS WERE WORN AND THE RUBBER KEYPAD IS PEELING OFF AT THE BOTTOM. THE PUMP POWERS ON AND DISPLAY VERIFY SCREEN. THE OK AND CONTRAST BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND THE OTHER BUTTONS RESPONDED APPROPRIATELY. EVALUATION REVEALED THAT WAS CONTAMINATION UNDER ALL KEY CONTACTS. THERE WAS A CRACK BETWEEN THE DISPLAY LENS AND THE CASE SEAL. THERE WAS MOISTURE CORROSION FOUND IN THE KEYPAD FLEX/CONNECTOR. THE DISPLAY LENS WAS ALSO SCRATCHED.

    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 W/MOISTURE) ISSUE. THE REPORTER STATED THE OK BUTTON WAS INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES TO ENGAGE. THE REPORTER NOTED CLOUDINESS/ MOISTURE BEHIND THE DISPLAY SCREEN. 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
    272727 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR