BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4842738 · Received June 12, 2015

    Report

    Report Number
    2531779-2015-19682
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    May 30, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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 12/03/2015 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED TO ANIMAS AND EVALUATED ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: ALL OF THE KEYPAD BUTTONS WERE NORMALLY RESPONSIVE. NO CONTAMINATION WAS FOUND UNDERNEATH THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A REPORTER CONTACTED ANIMAS ALLEGING THAT ALL OF THE KEYPAD BUTTONS WERE INTERMITTENTLY UNDER OR HYPER RESPONSIVE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384583 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR