BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3181276 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08702
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/23/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE KEYPAD BUTTONS WERE RESPONSIVE TO USER INPUT. THE KEYPAD BUTTONS WERE FOUND TO HAVE NORMAL SPRING BACK AND CLICK. NO CONTAMINATION WAS FOUND UNDER THE KEY CONTACTS. UNRELATED TO THE COMPLAINT, THE BOLUS BUTTON WAS FOUND TO BE TORN; THE BOLUS BUTTON WAS FOUND TO BE RESPONSIVE.

    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 THE UP, DOWN, AND OK 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
    282489 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR