BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3071541 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04816
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT ALL KEYPAD BUTTONS RESPONDED AS EXPECTED. THERE WAS NO PHYSICAL DAMAGE TO THE KEYPAD. NO DEFECT WAS FOUND ON INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE KEYPAD BUTTONS DO NOT ALWAYS WORK. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLE SHOOTING. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172853 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR