BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3211801 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09876
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 8/13/2013 WITH THE FOLLOWING FINDINGS: THE RUBBER KEYPAD WAS FOUND TO BE INTACT. ALL OF THE KEYPAD BUTTONS RESPONDED APPROPRIATELY. THERE WAS NO EVIDENCE OF CONTAMINATION UNDER THE CONTACTS. THERE WAS A PUMP CASE LEAK FOUND DURING TESTING. THE PUMP CASE WAS CRACKED AT THE TOP RIGHT CORNER OF THE DISPLAY LENS. THERE WAS MOISTURE CORROSION IN THE PUMP COMPARTMENT. THE PUMP COVER WAS REMOVED AND FORCE SENSOR CIRCUIT WAS INSPECTED, AN INTERMITTENT CONDITION WAS FOUND TO THE FORCE SENSOR FLEX PINS DUE A CRACKED TRACE NEAR TO THE PIN.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER STATED ALL BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AFTER SWIMMING. THE REPORTER NOTED MOISTURE BEHIND THE DISPLAY SCREEN. 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
    311278 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR