BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4103186 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26870
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/17/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO DAMAGE OBSERVED TO THE KEYPAD. THE KEYPAD BUTTONS WERE TESTED AND WERE CONFIRMED TO BE FULLY FUNCTIONAL. THE KEYPAD WAS REMOVED AND NO BUTTON CONTACT DEFECTS WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE UP, DOWN, AND OK BUTTONS WERE UNDER RESPONSIVE TO BUTTON PRESSES. THE REPORTER INDICATED THAT THERE WAS NO KNOWN MOISTURE INGRESS TO THE PUMP AND CONFIRMED THAT THERE WAS NO ALLEGED IMPACT ON THE PUMP¿S INSULIN DELIVERY. 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
    582435 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR