BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6511148 · Received April 21, 2017

    Report

    Report Number
    2531779-2017-08252
    Event Type
    Malfunction
    Date Received
    April 21, 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 6 ALLEGATIONS OF A MALFUNCTION, 3 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 2 WERE FOUND TO BE MALFUNCTIONING DUE TO A DISPLAY CLOUDY WITH MOISTURE ISSUE. THIS REPORT IS PROCESSED UNDER EXEMPTION NUMBER E2015053. THIS MDR REPORT IS PART OF THE 227 PILOT PROGRAM.

    Additional Manufacturer Narrative · 0

    FOLOW UP #1 07/29/2017 DEVICE EVALUATION: IN Q2 2017, THERE WERE 4 INSTANCES OF CLOUDY W/ MOISTURE FAILURE FOUND DURING INVESTIGATION. 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 6 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THE ONE TOUCH PING MODEL PUMP EXPERIENCED A CARTRIDGE COMPARTMENT AND CAP ISSUE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THE PATIENTS ASSOCIATED WITH THIS ALLEGATION RANGED FROM 183-210 POUNDS AND BETWEEN 2 AND 68 YEARS OF AGE. OF THE REPORTED PATIENTS, 3 WERE MALE AND 3 WERE FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294347 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1