BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3911572 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19004
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 11/20/2015 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/05/2015 WITH THE FOLLOWING FINDINGS: 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. ON INVESTIGATION, THE ALLEGED MOISTURE INGRESS ISSUE WAS VERIFIED. A PUMP CASING CRACK WAS FOUND NEAR THE TOP RIGHT CORNER OF THE DISPLAY. A LEAK TEST SHOWED LEAKS AT THE CASING CRACK AS WELL AS AT THE DISPLAY LENS WHERE THE CASING WAS DAMAGED. THE PUMP POWERED UP TO THE VERIFY SCREEN WITH AUDITORY AND VIBRATORY FEATURES. NO TACTILE ISSUES WERE FOUND WITH THE BUTTONS. PUMP CASING WAS OPENED AND EVIDENCE OF MOISTURE INTRUSION WAS FOUND THROUGHOUT THE PUMP INTERIOR. UNRELATED TO THE COMPLAINT, THE DISPLAY WAS FOUND TO BE DIM WITH A PINKISH CONTRAST.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. REPORTEDLY, MOISTURE WAS OBSERVED BEHIND THE DISPLAY WITH NO DAMAGE TO THE PUMP NOTED. 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
    390936 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR