BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4092882 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26371
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/14/2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH A PEELING KEYPAD COVER. DURING TESTING, THE UP AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE, AND THE CONTRAST BUTTON WAS UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL OF THE KEYPAD BUTTON CONTACTS. UNRELATED TO THE INITIAL COMPLAINT, THE AUDIO BOLUS BUTTON COVER WAS FOUND TO BE TORN AND EXPOSING THE WHITE SLUG; HOWEVER, THE BOLUS BUTTON WAS NORMALLY RESPONSIVE. ALSO UNRELATED, THE DISPLAY SCREEN WAS DIM AND DISCOLORED, AND THE CARTRIDGE COMPARTMENT WAS OBSERVED TO BE CRACKED. THERE WAS NO VISIBLE DAMAGE TO THE CARTRIDGE CAP AND WAS ABLE TO FULLY SECURE ONTO THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (DAMAGE PRIOR TO TACTILE CHANGE) ISSUE. THE REPORTER ALLEGED THAT THE UP ARROW KEYPAD BUTTON WAS OVER RESPONSIVE, AND THAT THE KEYPAD COVER WAS MISSING/PEELING AND TORN/PUNCTURED. 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
    571418 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR