BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3960515 · Received July 28, 2014

    Report

    Report Number
    2531779-2014-21559
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 09/09/2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE PUMP POWERED ON WITH A TEST DISPLAY SCREEN TO FUNCTIONING DISPLAY SCREEN. THE PUMP WAS OPENED AND NO EVIDENCE OF MOISTURE WAS FOUND ON INTERNAL COMPONENTS OF THE PUMP. UNRELATED TO THE INITIAL DISPLAY SCREEN, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED WITH EVIDENCE OF CORROSION INSIDE. THE LEAK TEST FAILED DUE TO THE BATTERY COMPARTMENT CRACK. ALSO UNRELATED, THE CONTRAST KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE CONTRAST BUTTON CONTACT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (CLOUDY W/ MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THERE WAS EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN AND THAT THE DISPLAY SCREEN COULD NOT BE READ SAFELY. 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
    439132 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR