BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3211244 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09859
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 08/23/2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD BUTTON SYMBOLS WERE FOUND TO BE WORN OFF; HOWEVER, NO DAMAGE OR PEELING WAS OBSERVED TO THE KEYPAD COVER. THERE WAS VISIBLE MOISTURE UNDER THE DISPLAY LENS. DURING TESTING, THE UP ARROW, DOWN ARROW AND CONTRAST KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE AND REQUIRED INCREASED FORCE TO ENGAGE; THE OK BUTTON RESPONDED APPROPRIATELY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS. THE PUMP FAILED A LEAK TEST DUE TO A CRACK IN UPPER RIGHT CORNER OF THE DISPLAY LENS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED DISPLAY SCREEN. A TEST DISPLAY SCREEN WAS INSERTED AND FOUND TO FUNCTION PROPERLY WITH NO VISIBLE SIGNS OF DISCOLORATION. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. 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.(B)(4).

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) 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
    310647 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR