BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3930124 · Received July 11, 2014

    Report

    Report Number
    2531779-2014-19785
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    July 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 08/28/2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THERE WAS VISIBLE EVIDENCE OF MOISTURE BEHIND THE DISPLAY LENS. DUE TO THE MOISTURE CONTAMINATION, THE PUMP POWERED ON TO A DISTORTED DISPLAY SCREEN WITH FUNCTIONING AUDITORY AND VIBRATORY FEATURES; A POWER LOSS WAS NOT OBSERVED. THE BATTERY CAP WAS ABLE TO FULLY SECURE ONTO THE PUMP, AND THERE WAS EVIDENCE OF MOISTURE CONTAMINATION ON THE INTERIOR OF THE BATTERY CAP. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. THE LEAK TEST FAILED DUE TO A BATTERY COMPARTMENT CRACK. THE KEYPAD BUTTONS WERE UNRESPONSIVE DUE TO INTERNAL MOISTURE DAMAGE. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION WAS FOUND UNDER ANY OF THE KEYPAD BUTTON CONTACTS. THE PUMP WAS OPENED AND EVIDENCE OF MOISTURE WAS FOUND ON THE INTERIOR COMPONENTS OF THE PUMP. THE PUMP WAS OPENED AND EVIDENCE OF MOISTURE WAS FOUND ON ALL INTERNAL COMPONENTS OF THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. IT WAS ALLEGED THAT THERE WAS MOISTURE VISIBLE BEHIND THE DISPLAY. 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
    408006 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR