BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3875125 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17148
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT ALL OF THE KEYPAD BUTTONS RESPONDED PROPERLY. THE KEYPAD COVER WAS REMOVED AND NO EVIDENCE OF CONTAMINATION OR DAMAGE WAS OBSERVED UNDER ANY OF THE KEY CONTACTS. A VISUAL INSPECTION FROM THE EXTERIOR OF THE PUMP DID NOT SHOW ANY EVIDENCE OF MOISTURE INGRESS. HOWEVER, A CRACK WAS OBSERVED ON THE BATTERY COMPARTMENT AND THE PUMP FAILED THE LEAK TEST. THE PUMP WAS OPENED AND CORROSION WAS OBSERVED ON INTERNAL COMPONENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. IT WAS REPORTED THAT THE DOWN ARROW, CONTRAST, AND OK KEYPAD BUTTONS WERE UNDER RESPONSIVE TO USER PRESSES. MOISTURE WAS ALLEGEDLY VISIBLE BEHIND THE PUMP DISPLAY LENS. 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
    352456 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR