BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 7955476 · Received October 11, 2018

    Report

    Report Number
    2531779-2018-18170
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Report Date
    October 1, 2018
    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

    OF THE 79 ALLEGATIONS OF A MALFUNCTION, 48 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 15 WERE FOUND TO BE MALFUNCTIONING DUE TO TRANSCEIVER CONNECTOR FAILURES.

    Additional Manufacturer Narrative · 1

    IN QUARTER 4 OF 2018, THERE WERE 5 INSTANCES OF CS 052/053/054/055 SLEEP FAILURE FOUND DURING INVESTIGATION. THIS REPORT IS PROCESSED UNDER THE VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 79</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 4-74 YEARS OF AGE AND BETWEEN 15 AND 275 POUNDS. OF THE REPORTED PATIENTS, 35 WERE MALE, 35 WERE FEMALE, AND WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795696 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1