BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4220679 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31220
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 04/22/2015 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/10/2015 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. ON INVESTIGATION, THE ALLEGED BUTTON TACTILE ISSUE WAS DUPLICATED. THE PUMP POWERED UP TO THE DISPLAY WITH AUDITORY AND VIBRATORY FEATURES. THE KEYPAD COVER WAS INTACT WHILE ALL THE KEYPAD BUTTONS RESPONDED INTERMITTENTLY. REMOVAL OF THE KEYPAD COVER FOUND CONTAMINATION UNDER THE CONTRAST BUTTON CONTACT. UNRELATED TO THE COMPLAINT, THE INVESTIGATION FOUND THAT THE BATTERY COMPARTMENT WAS CRACKED FROM BELOW THE GRIP PAD TO THE BOTTOM.

    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 TACTILE ISSUE WITH THE KEYPAD BUTTONS. IT WAS REPORTED THAT THERE WAS NO DAMAGES TO THE KEYPAD AND NO DELIVERY ISSUES WERE NOTED. 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
    701705 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR