BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 7700034 · Received July 18, 2018

    Report

    Report Number
    2531779-2018-13072
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Report Date
    July 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 40 ALLEGATIONS OF A MALFUNCTION, 30 PUMPS WERE RETURNED TO ANIMAS AND INVESTIGATED. OF THE INVESTIGATED PUMPS, 8 WERE FOUND TO BE MALFUNCTIONING DUE TO "REASON FOR FAILURE."

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01-OCT-2018 WITH THE FOLLOWING FINDINGS: IN QUARTER 3 OF 2018, 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 40 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 RANGES FROM 5-74 YEARS OF AGE AND BETWEEN 20 AND 220 POUNDS. OF THE REPORTED PATIENTS, 18 WERE MALE AND 22 WERE FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541453 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1