BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3220953 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10316
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/02/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 09/09/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, MOISTURE WAS VISIBLE BEHIND THE DISPLAY LENS. DURING TESTING, THE PUMP POWERED ON TO THE VERIFY SCREEN WITH AUDIBLE TONES AND NO VIBRATORY FUNCTION. THE DISPLAY WAS FOUND TO BE MULTI-COLORED. ALL OF THE KEYPAD BUTTONS WERE UNRESPONSIVE DUE TO MOISTURE DAMAGE. THE CONTRAST KEYPAD BUTTON RESPONDED APPROPRIATELY TO BUTTON PRESSES. DURING EVALUATION, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED FROM THE THREADS TO THE CASE SEAL. THERE WAS NO EVIDENCE OF MOISTURE IN THE BATTERY COMPARTMENT. THE BATTERY COMPARTMENT CAP WAS NOT ABLE TO FULLY TIGHTEN DUE TO THE BATTERY COMPARTMENT CRACK. DURING TESTING, POWERLOSS WAS NOT OBSERVED. A LEAK TEST SHOWED A LEAK AT THE BATTERY COMPARTMENT CRACK. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE WAS FOUND THROUGHOUT THE INSIDE OF THE PUMP. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT THE PUMP WOULD NOT POWER ON AFTER EXPOSURE TO WATER WHILE SWIMMING. REPORTEDLY, THERE WAS WATER IN THE BATTERY COMPARTMENT AND 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
    321306 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR