BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3130173 · Received May 24, 2013

    Report

    Report Number
    2531779-2013-07057
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO MOISTURE CORROSION VISIBLE IN "CARTRIDGE COMPARTMENT" OR ¿BATTERY COMPARTMENT¿. ¿NO¿ LEAKS WAS FOUND DURING TESTING. PUMP COVER WAS REMOVED TO INSPECT INTERNAL COMPONENTS. MOISTURE CORROSION VISIBLE ON INTERNAL COMPONENTS. KEYPAD IS FULLY INTACT, WITH NO PEELING OR DAMAGE OBSERVED. ¿CONTRAST¿,"UP","DOWN" AND "OK" KEYS RESPOND. KEYPAD WAS REMOVED TO INVESTIGATE,NO EVIDENCE OF KEYPAD CONTAMINATION WAS LOCATED, UNDER ¿CONTRAST¿,"UP","DOWN" AND "OK" CONTACT BUTTON. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. PUMP WAS EXPOSED TO WATER. 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
    230827 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR