BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3232654 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11158
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/04/2013 WITH THE FOLLOWING FINDINGS: 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. THE KEYPAD COVER WAS OBSERVED TO BE TORN AT THE OK BUTTON. THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE UNRESPONSIVE; THE CONTRAST BUTTON RESPONDED PROPERLY. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION WAS FOUND UNDER ANY KEY CONTACTS. CORROSION DUE TO MOISTURE WAS OBSERVED ON THE KEYPAD FLEX AND CONNECTOR.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE: AFTER WATER EXPOSURE, DAD STATES THAT HE IS UNABLE TO CONFIRM THE VERIFICATION SCREEN. BUTTONS ARE NOT RESPONDING. MOISTURE FOUND IN BATTERY COMPARTMENT AND BEHIND THE DISPLAY. DAD IS CONTACTING HEALTH CARE PROVIDER FOR ALTERNATE METHOD OF INSULIN DELIVERY UNTIL REPLACEMENT PUMP ARRIVES. 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
    335483 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR