BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3153554 · Received June 8, 2013

    Report

    Report Number
    2531779-2013-07892
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    May 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/31/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/10/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE COMPLAINT OF A BLANK DISPLAY WAS NOT DUPLICATED; THE DISPLAY WAS CLEAR AND LEGIBLE AND FUNCTIONED PROPERLY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. STATES THAT SHE CHANGED THE BATTERY TODAY AS SCHEDULED AND THE DISPLAY WOULDN¿T LIGHT UP. AUDIO TONES AND VIBRATION ARE FUNCTIONING. PARENT ATTEMPTED TO CHANGE TO ANOTHER NEW BATTERY AND THE ISSUE CONTINUED. PARENT DENIES ANY TRAUMA OR MOISTURE TO THE PUMP. NO DAMAGE NOTED TO THE PUMP OR BATTERY CAP. 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
    258362 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR