BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3896241 · Received June 26, 2014

    Report

    Report Number
    2531779-2014-18402
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/05/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH NO VISIBLE DAMAGE TO THE KEYPAD, AND VISIBLE EVIDENCE OF MOISTURE IN THE DISPLAY. DURING TESTING, ALL OF THE KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL OF THE KEYPAD BUTTON CONTACTS. THE LEAK TEST WAS PERFORMED AND NO LEAKS WERE DETECTED. THE PUMP WAS OPENED AND REMOVED FROM THE CASE, AND MOISTURE AND CORROSION WERE FOUND ON ALL OF THE INTERNAL SURFACES.

    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 W/MOISTURE) ISSUE. REPORTEDLY, ALL THE BUTTONS WERE UNDER RESPONSIVE AND MOISTURE WAS OBSERVED BEHIND THE DISPLAY AND THE INFRARED WINDOW. THE REPORTER DID NOT NOTE ANY DAMAGE TO THE KEYPAD COVER OR 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
    374590 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR