BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3882527 · Received June 18, 2014

    Report

    Report Number
    2531779-2014-17556
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    June 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 08/06/2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH NO VISIBLE DAMAGE TO THE KEYPAD COVER AND VISIBLE EVIDENCE OF MOISTURE BEHIND THE DISPLAY LENS. DURING TESTING, ALL OF THE KEYPAD BUTTONS WERE NORMALLY RESPONSIVE. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE CONTRAST AND UP ARROW KEYPAD BUTTON CONTACTS. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE LEAK TEST REVEALED A LEAK AT A CRACK IN THE PUMP CASING NEAR THE DISPLAY. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE WAS OBSERVED INSIDE THE PUMP AND ON THE KEYPAD FLEX CABLE AND CONNECTOR. 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.

    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 THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS WERE UNDER RESPONSIVE TO USER PRESSES. MOISTURE WAS ALSO 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
    357270 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR