BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3922183 · Received July 9, 2014

    Report

    Report Number
    2531779-2014-19412
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 09/11/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THERE WAS VISIBLE EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN. THE PUMP FAILED TO POWER ON. THE PUMP WAS RETURNED WITH NO VISIBLE DAMAGE TO THE KEYPAD COVER. THE KEYPAD BUTTONS COULD NOT BE INVESTIGATED DUE TO LACK OF POWER TO THE PUMP. THE KEYPAD COVER WAS REMOVED AND NO DAMAGE WAS FOUND TO THE KEYPAD BUTTON CONTACTS. THE PUMP WAS OPENED AND MOISTURE WAS EVIDENT INSIDE THE PUMP. UNRELATED TO THE INITIAL COMPLAINT, THE PUMP CASE WAS CRACKED. THE LEAK TEST FAILED DUE TO A CRACKED PUMP CASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. IT WAS REPORTED THAT ALL OF THE KEYPAD BUTTONS WERE UNDER RESPONSIVE. MOISTURE WAS ALLEGEDLY VISIBLE BEHIND THE PUMP DISPLAY LENS. 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
    400097 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR