BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3883458 · Received June 19, 2014

    Report

    Report Number
    2531779-2014-17604
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 14, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/17/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/08/2014 WITH THE FOLLOWING FINDINGS:A VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE KEYPAD COVER WAS INTACT. THE PUMP POWERED UP WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. ALL THE KEYPAD BUTTONS RESPONDED INTERMITTENTLY. REMOVAL OF THE KEYPAD COVER FOUND CONTAMINATION UNDER ALL OF THE BUTTON CONTACTS. UNRELATED TO THE BUTTON ISSUE, IT WAS OBSERVED THAT THE VERIFY SCREEN WAS DIM AND DISCOLORED AND THE BATTERY CAP WAS DAMAGED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. REPORTEDLY, THE ¿UP¿, ¿DOWN¿ AND ¿OK¿ BUTTONS WERE UNDER RESPONSIVE. IT WAS REPORTED THAT THE KEYPAD COVER WAS UNDAMAGED AND THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP. THE REPORTER DID NOT NOTE ANY DELIVERY ISSUE. 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
    361523 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR