BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222237 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10376
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 FOLLOW-UP #1 SUBMITTED 08/22/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 07/26/2013 WITH THE FOLLOWING RESULTS: PUMP RETURNED WITH VISIBLE MOISTURE IN THE DISPLAY LENS. PUMP DOES NOT POWER ON; NO AUDIBLE OR VIBRATORY SOUNDS. THE ATTEMPT TO DOWNLOAD THE PUMP HISTORY AND BLACK BOX WAS UNSUCCESSFUL. THE AUDIO BOLUS BUTTON COVER WAS OBSERVED TO BE MISSING. IN-HOUSE LEAK TEST SHOWS AUDIO BOLUS BUTTON LEAK.REMOVED PUMP COVER; INTERNAL MOISTURES INGRESS FOUND IN THE PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. THE REPORTER STATED WHILE ON VACATION, THE PATIENT WAS IN THE WATER OFTEN. THE REPORTER STATED THE PUMP¿S DISPLAY IS BLANK WITH MOISTURE BUT THE PUMP STILL HAS AUDIO AND VIBRATION TONES. PT¿S MOTHER STATES THERE IS WATER IN THE DISPLAY AREA. 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
    322825 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR