BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4093146 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26385
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 11/05/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE KEYPAD COVER WAS PEELING FROM ITS BASE. EVALUATION REVEALED THAT THE CONTRAST KEYPAD BUTTON WAS UNRESPONSIVE: THE REPORTED ISSUE WAS NOT DUPLICATED, AS AN UNDER-RESPONSIVE CONDITION OF THE UP ARROW, DOWN ARROW, AND/OR OK KEYPAD BUTTONS WAS NOT FOUND. THE KEYPAD COVER WAS REMOVED, AND THE CONTRAST KEY CONTACT WAS OBSERVED TO BE INVERTED; THIS DEVICE FAILURE CAUSED THE OBSERVED KEYPAD-RESPONSIVENESS ISSUE. THE UP ARROW, DOWN ARROW, AND OK KEY CONTACTS WERE OBSERVED TO BE FREE OF DAMAGE, DEFECT, AND CONTAMINATION. THE OBSERVED DEVICE FAILURES ARE UNRELATED TO THE REPORTED ISSUE. 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 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 BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE UNDER-RESPONSIVE. 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
    573074 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR