BEUDAMED
    FDA Adverse Event Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4133869 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28113
    Date Received
    October 1, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 4/3/15. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/23/2015 WITH THE FOLLOWING FINDINGS: NO DEFECT FOUND. KEYPAD IS INTACT, ALL BUTTONS RESPONSIVE DURING INVESTIGATION. REMOVED KEYPAD TO INSPECT UNDER CONTACTS, NO CONTAMINATION FOUND UNDER CONTACTS..UNABLE TO DUPLICATE COMPLAINT OF UNRESPONSIVE KEYPAD ISSUE DURING THIS INVESTIGATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE REPORTER CONTACTED ANIMAS, ALLEGING A TACTILE CHANGES/UNRESPONSIVE KEYPAD ISSUE. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610838 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR