BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3922977 · Received July 9, 2014

    Report

    Report Number
    2531779-2014-19436
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 08/13/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD COVER WAS OBSERVED TO BE TORN NEAR THE DOWN ARROW BUTTON. EVALUATION REVEALED THAT ALL OF THE KEYPAD BUTTONS WERE PROPERLY RESPONSIVE; THE EVENT REPORTED IN THE INITIAL COMPLAINT WAS NOT DUPLICATED. THE PUMP PASSED A LEAK TEST. THE KEYPAD COVER WAS REMOVED, AND EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL OF THE KEY CONTACTS. THE PUMP CASE WAS REMOVED, AND EVIDENCE OF MOISTURE INGRESS WAS NOT OBSERVED ON INTERNAL COMPONENTS. UNRELATED TO THE REPORTED EVENT, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CNGS PRIOR DMG W/MOIST) ISSUE. IT WAS REPORTED THAT THE DOWN ARROW, UP ARROW, AND OK KEYPAD BUTTONS WERE UNDER RESPONSIVE. THE REPORTER ALLEGED THAT THE KEYPAD WAS TORN/PUNCTURED. IT WAS NOTED THAT THERE WAS MOISTURE/CORROSION IN THE KEYPAD. 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
    399768 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR