BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3791413 · Received May 5, 2014

    Report

    Report Number
    2531779-2014-12502
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 26, 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

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE KEYPAD COVER WAS UNDAMAGED. THE PUMP POWERED UP TO THE VERIFY SCREEN WITH THE AUDIBLE BUT NO VIBRATORY FUNCTIONS. THE ¿OK¿ BUTTON RESPONDED INTERMITTENTLY WHILE THE REMAINING BUTTONS RESPONDED PROPERLY. REMOVAL OF KEYPAD COVER DID NOT FIND ANY ANOMALIES WITH THE BUTTON CONTACTS. UNRELATED TO THE BUTTON ISSUE, MOISTURE WAS OBSERVED BEHIND THE DISPLAY SCREEN AND ADDITIONAL EVIDENCE OF MOISTURE INGRESS WAS FOUND INSIDE THE PUMP WHEN IT WAS OPENED TO INVESTIGATE.

    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. IT WAS REPORTED THAT UP, DOWN, OKAY, AND CONTRAST 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
    266317 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR