BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3882499 · Received June 18, 2014

    Report

    Report Number
    2531779-2014-17539
    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
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION SHOWED MOISTURE WAS PRESENT BEHIND THE DISPLAY LENS. NO EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND INSIDE THE BATTERY COMPARTMENT. THE BATTERY COMPARTMENT AND PUMP CASE WERE FOUND TO BE CRACKED. THE PUMP POWERED UP PROPERLY, BUT WITH A BLANK DISPLAY DUE TO INTERNAL MOISTURE DAMAGE. THE PUMP FAILED A LEAK TEST DUE TO A LEAK AT THE PUMP CASE CRACK. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS OBSERVED ON INTERNAL COMPONENTS. THE INITIAL COMPLAINT OF A FLASHING DISPLAY COULD NOT BE EVALUATED DUE TO THE PRESENCE OF A BLANK SCREEN. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (FLASHING DISPLAY W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THE DISPLAY WAS FLASHING. IT WAS NOTED THAT THERE WAS MOISTURE/CORROSION IN THE BATTERY COMPARTMENT AND BEHIND THE DISPLAY. 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
    357249 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR