BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 8226591 · Received January 8, 2019

    Report

    Report Number
    2531779-2019-00171
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Report Date
    January 1, 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

    OF THE 25 ALLEGATIONS OF A MALFUNCTION, 7 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, WERE FOUND TO BE MALFUNCTIONING DUE TO TRANSCEIVER CONNECTOR FAILURES. THIS REPORT IS PROCESSED UNDER THE VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: IN QUARTER 1 OF 2019, THERE WERE 3 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> 25</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 38 AND 260 POUNDS. OF THE REPORTED PATIENTS, 14 WERE MALE AND 11 WERE FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19903 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1