BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6515592 · Received April 24, 2017

    Report

    Report Number
    2531779-2017-08403
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Report Date
    March 31, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    OF THE 5 ALLEGATIONS OF A MALFUNCTION, 2 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 0 WERE FOUND TO BE MALFUNCTIONING. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THE ONE TOUCH PING MODEL PUMP EXPERIENCED A TIME LOSS/GAIN ISSUE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THE PATIENTS ASSOCIATED WITH THIS ALLEGATION RANGED FROM 170-170 POUNDS AND BETWEEN 10 AND 64 YEARS OF AGE. OF THE REPORTED PATIENTS, 2 WERE MALE, 3 WERE FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296568 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1