BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 8477894 · Received April 3, 2019

    Report

    Report Number
    2531779-2019-02387
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Report Date
    March 31, 2019
    Manufacturer
    ANIMAS LLC
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION:IN QUARTER 2 OF 2019, THERE WERE 2 INSTANCES OF CS 052/053/054/055 SLEEP FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER THE VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM.

    Additional Manufacturer Narrative · 1

    OF THE 20 ALLEGATIONS OF A MALFUNCTION, 9 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 3 WERE FOUND TO BE MALFUNCTIONING DUE TO CRACKED OR TORN TRANSCEIVER FLEX. THIS REPORT IS PROCESSED UNDER THE VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 20</NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THE ONE TOUCH PING MODEL PUMP EXPERIENCED A CS 052/053/054/055 SLEEP ISSUE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. THE PATIENTS ASSOCIATED WITH THIS ALLEGATION RANGED FROM 4-70 YEARS OF AGE AND BETWEEN 100 AND 247 POUNDS. OF THE REPORTED PATIENTS, 7 WERE MALE, 13 WERE FEMALE, AND 0 WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273077 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1