BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4083201 · Received September 11, 2014

    Report

    Report Number
    2531779-2014-25953
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/22/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD RUNNER WAS INTACT. THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND THE CONTRAST AND OK KEYS RESPONDED APPROPRIATELY. EVALUATION REVEALED CONTAMINATION UNDER THE CONTRAST, UP ARROW AND DOWN ARROW KEYPAD BUTTONS. ALL OF THE BUTTONS SPRING BACK OR CLICK NORMALLY. BATTERY COMPARTMENT CRACKED FROM THE TOP. USE RETURNED BATTERY CAP, BATTERY CAP DOES TIGHTEN FULLY.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE BATTERY COMPARTMENT WAS CRACKED. THE REPORTER CONFIRMED THAT THERE WAS NO NOTED POWER ISSUE WITH THE PUMP AND NO NOTED MOISTURE INGRESS INTO THE PUMP. 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
    562828 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR